Notice2021-23075
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications
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Published
October 22, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.
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<title>Federal Register, Volume 86 Issue 202 (Friday, October 22, 2021)</title>
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[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58675-58681]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1037]
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 216 abbreviated new drug applications (ANDAs)
from multiple holders of those ANDAs. The basis for the withdrawal is
that these ANDA holders have repeatedly failed to submit required
annual reports for those ANDAs.
DATES: Approval is withdrawn as of November 22, 2021.
FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-
402-4718, <a href="/cdn-cgi/l/email-protection#f9b398949c8ad7b198978b988d8d80b99f9d98d791918ad79e968f"><span class="__cf_email__" data-cfemail="da90bbb7bfa9f492bbb4a8bbaeaea39abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The holders of an approved application to
market a new drug for human use are required to submit annual reports
to FDA concerning their approved application in accordance with
Sec. Sec. 314.81 and 314.98 (21 CFR 314.81 and 314.98). In the Federal
Register of January 9, 2020 (85 FR 1160), FDA published a notice
offering an opportunity for a hearing (NOOH) on a proposal to withdraw
approval of 249 ANDAs because the holders of those ANDAs had repeatedly
failed to submit the required annual reports for those ANDAs
(``Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249
Abbreviated New Drug Applications; Opportunity for a Hearing'').\1\ The
holder of ANDA 085882, ANDA 086262, and ANDA 0866263 responded to the
NOOH and requested a hearing. The remaining holders of those ANDAs did
not respond to the NOOH. Failure to file a written notice of
participation and request for hearing as required by Sec. 314.200
constitutes an election by those holders of the ANDAs not to make use
of the opportunity for a hearing concerning the proposal to withdraw
approval of their ANDAs and a waiver of any contentions concerning the
legal status of the drug products. Therefore, FDA is withdrawing
approval of the 216 applications listed in table 1.
---------------------------------------------------------------------------
\1\ 85 FR 1160, published on January 9, 2020, incorrectly listed
249 as the number of the ANDAs FDA proposed to withdrawal. 85 FR
1160 listed 248 ANDAs in the table included in the notice.
---------------------------------------------------------------------------
I. Annual Reports Submitted
In response to the NOOH, one firm requested a hearing and had
previously submitted an annual report for each of its three ANDAs.
Therefore, FDA rescinds its proposal to withdraw approval of the
following three ANDAs:
Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920:
<bullet> ANDA 085882, DUVOID (bethanechol chloride) Tablets, 50
milligrams (mg)
<bullet> ANDA 086262, DUVOID (bethanechol chloride) Tablets, 10 mg
<bullet> ANDA 086263, DUVOID (bethanechol chloride) Tablets, 25 mg
Another three firms notified the Agency that they had submitted an
annual report for each of its ANDAs listed in the NOOH. Therefore, FDA
rescinds its proposal to withdraw approval of the following eight
ANDAs:
Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY
11716:
<bullet> ANDA 062869, CEPHALEXIN Capsules USP, EQ 500 mg base
<bullet> ANDA 062870, CEPHALEXIN Capsules USP, EQ 250 mg base
<bullet> ANDA 074988, ASPIRIN, CAFFEINE, AND ORPHENADRINE CITRATE
Tablets, 385 mg/30 mg/25 mg, and 770 mg/60 mg/50 mg
<bullet> ANDA 081145, ASPIRIN AND METHOCARBAMOL Tablets, 325 mg/400 mg
MIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm.
PS049, Stanford, CA 94305:
<bullet> ANDA 204472, FLUDEOXYGLUCOSE F-18 Injection USP, 20-300
millicuries (mCi)/milliliters (mL)
<bullet> ANDA 204517, SODIUM FLUORIDE F-18 Injection, 10-200 mCi/mL
<bullet> ANDA 204535, AMMONIA N-13 Injection USP, 3.75-37.5 mCi/mL
Milex Products, Inc., 5915 Northwest Hwy., Chicago, IL 60631:
<bullet> ANDA 072196, MILOPHENE (clomiphene citrate) Tablets, 50 mg
II. Previously Consolidated Application
Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893, notified the Agency
that ANDA 084631, QUINIDINE SULFATE Tablets USP, 200 mg, had previously
been consolidated with ANDA 088072. Therefore, FDA rescinds its
proposal to withdraw approval of this ANDA.
[[Page 58676]]
III. Previously Transferred Application
Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017, notified the Agency that ANDA 060074, PENICILLIN G
POTASSIUM for Injection, 20,000,000 units/vial, had previously been
transferred to Cultor Food Science, Inc. Therefore, FDA rescinds its
proposal to withdraw approval of this ANDA.
IV. Requests To Withdraw Approval
In response to the NOOH, 13 firms notified the Agency that they no
longer market 15 of the ANDAs listed in the NOOH and had previously
submitted written requests for withdrawal for the following ANDAs:
1. Parkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620,
notified the Agency that they no longer market the product for ANDA
060521, HUMATIN (paromomycin sulfate) Capsules USP, Equivalent to (EQ)
250 mg base. On May 12, 2021 (86 FR 26058), the Agency withdrew
approval of this ANDA at the written request of the applicant.
2. Roerig Division of Pfizer Inc., 235 East 42nd St., New York, NY
10017, notified the Agency that they no longer market the product for
ANDA 060709, OLEANDOMYCIN Injection. On July 21, 2020 (85 FR 44096),
the Agency withdrew approval of this ANDA under the written request of
the applicant.
3. Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001,
notified the Agency that they no longer market the product for ANDA
061034, LINCOMYCIN HYDROCHLORIDE (HCl) Powder. On May 12, 2021, the
Agency withdrew approval of this ANDA under the written request of the
applicant.
4. Lederle Laboratories, Division of American Cyanamid Co., 401
North Middletown Rd., Pearl River, NY 10965, notified the Agency that
they no longer market the product for ANDA 061064, NYSTATIN Ointment.
On May 12, 2021, the Agency withdrew approval of this ANDA under the
written request of the applicant.
5. Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St.,
New York, NY 10017, notified the Agency that they no longer market the
product for ANDA 061087, BENZOCAINE, OXYTETRACYCLINE HCl, and POLYMYXIN
B SULFATE OTIC Solution. On July 21, 2020, the Agency withdrew approval
of this ANDA under the written request of the applicant.
6. Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950,
notified the Agency that they no longer market the product for ANDA
061652, OXYTETRACYCLINE Capsules. On May 12, 2021, the Agency withdrew
approval of this ANDA under the written request of the applicant.
7. AH Robins Co., 1211 Sherwood Ave., Richmond, VA 23220, notified
the Agency that they no longer market the product for ANDA 061701,
TETRACYCLINE Syrup, 125 mg/5 mL. On May 12, 2021, the Agency withdrew
approval of this ANDA under the written request of the applicant.
8. Warner Chilcott, Division of Warner Lambert-Pfizer, Inc., 235
East 42nd St., New York, NY 10017, notified the Agency that they no
longer market the products for ANDA 061725, TETRACYCLINE HCl Capsules,
250 mg and 500 mg, and ANDA 062175, TETRACYCLINE HCl Capsules, 250 mg.
On July 21, 2020, the Agency withdrew approval of these ANDAs under the
written request of the applicant.
9. Lederle Laboratories, Division of American Cyanamid Co., 1
Cyanamid Plaza, Wayne, NJ 07470, notified the Agency that they no
longer market the products for ANDA 061943, CHLORAMPHENICOL Ophthalmic
Solution, 0.5 percent; ANDA 062215, OXYTETRACYCLINE HCl Capsules. On
July 21, 2020, the Agency withdrew approval of these ANDAs under the
written request of the applicant.
10. Warner-Lambert Co. notified the Agency that they no longer
market the product for ANDA 062032, EYPAR (erythromycin stearate)
Tablets, EQ 250 mg base and EQ 500 mg base. On May 12, 2021, the Agency
withdrew approval of this ANDA under the written request of the
applicant.
11. Becton Dickinson and Co., Surgical System, 9450 South State
St., Sandy, UT 84070, notified the Agency that they no longer market
the product for ANDA 073416, E-Z SCRUB (chlorhexidine gluconate)
Topical Sponge, 4 percent. On January 8, 2020 (85 FR 909), the Agency
withdrew approval of this ANDA under the written request of the
applicant.
12. Lederle Laboratories, Division of American Cyanamid Co., Pearl
River, NY 10965-1215, notified the Agency that they no longer market
the products for ANDA 083001, TRIAMCINOLONE ACETONIDE Aerosol Foam
Emulsion. On May 12, 2021, the Agency withdrew approval of this ANDA
under the written request of the applicant.
13. Lederle Laboratories, Division of American Cyanamid Co., Pearl
River, NY 10965-1215, notified the Agency that they no longer market
the product for ANDA 084803, CHLORPROMAZINE HCl Tablets, 10 mg. On May
12, 2021, the Agency withdrew approval of this ANDA under the written
request of the applicant.
V. Previously Withdrawn Applications
In the Federal Register of September 25, 2020 (85 FR 60474), FDA
published a separate notice offering an opportunity for a hearing
(NOOH) on a proposal to withdraw approval of ANDAs because the holders
of those ANDAs had repeatedly failed to submit the required annual
reports and have failed to satisfy the requirement to have an approved
risk evaluation and mitigation strategy for the following ANDAs:
1. Everylife, 2021 15th Avenue West, Seattle, WA 98119: ANDA
085217, ACETAMINOPHEN and CODEINE PHOSPHATE Tablet, 325 mg/30 mg.
2. Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX
75093: ANDA 085638, ACETAMINOPHEN, ASPIRIN, and CODEINE, 150 mg/180 mg/
60 mg; ANDA 085639, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE
Capsule, 150 mg/180 mg/30 mg; ANDA 085640, ACETAMINOPHEN, ASPIRIN, and
CODEINE PHOSPHATE Capsule, 150 mg/180 mg/15 mg.
The holders of the applications did not respond to the Federal
Register NOOH of September 25, 2020. Failure to submit a written notice
of participation and request for hearing as required by Sec. 314.200
constitutes an election by those holders not to make use of the
opportunity for a hearing concerning the proposal to withdraw approval
of their ANDAs and a waiver of any contentions concerning the legal
status of the drug products. On April 9, 2021 (86 FR 18542), the Agency
withdrew approval of these ANDAs.
VI. No Response to NOOH Received
The holders of the other 216 applications did not respond to the
NOOH. Failure to submit a written notice of participation and request
for hearing as required by Sec. 314.200 constitutes an election by
those holders not to make use of the opportunity for a hearing
concerning the proposal to withdraw approval of their ANDAs and a
waiver of any contentions concerning the legal status of the drug
products. Therefore, the Director, Center for Drug Evaluation and
Research, is withdrawing approval of the 216 applications listed in
table 1.
[[Page 58677]]
Table 1--Approved ANDAs for Which Required Reports Have Not Been
Submitted
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 020374............... Inpersol-LC/LM with Fresenius USA, Inc.,
Dextrose 1.5% 2637 Shadelands Dr.,
(calcium chloride, Walnut Creek, CA
dextrose, magnesium 94598.
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 1.5 grams
(g)/100 mL; 5.08 mg/
100 mL; 538 mg/100
mL; 448 mg/100 mL.
Inpersol-LC/LM with
Dextrose 2.5%
(calcium chloride,
dextrose, magnesium
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 2.5 g/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
Inpersol-LC/LM with
Dextrose 3.5%
(calcium chloride,
dextrose, magnesium
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 3.5 g/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
Inpersol-LC/LM with
Dextrose 4.25%
(calcium chloride,
dextrose, magnesium
chloride, sodium
chloride, sodium
lactate)
Intraperitoneal
Solution, 18.4 mg/
100 mL; 4.25 g/100
mL; 5.08 mg/100 mL;
538 mg/100 mL; 448
mg/100 mL.
ANDA 040057............... Epinephrine and Eastman Kodak Co.,
Lidocaine 343 State St.,
Hydrochloride (HCl) Rochester, NY 14650.
Injection, 0.01 mg/
mL; 2% and 0.02 mg/
mL; 2%.
ANDA 040168............... Hydrocortisone and Wockhardt EU
Acetic Acid Otic Operations (Swiss)
Solution USP, 1%/2%. AG, c/o Morton Grove
Pharmaceuticals,
Inc., 6451 West Main
St., Morton Grove,
IL 60053.
ANDA 040192............... Prednisolone Syrup, WE Pharmaceuticals,
15 mg/5 mL. Inc., 1142 D St.,
P.O. Box 1142,
Ramona, CA 92065.
ANDA 060131............... Tetracycline HCl Leiner Health
Capsules. Products, Inc., 901
East 233rd St.,
Carson, CA 90745.
ANDA 060461............... Neomycin Sulfate Ambix Laboratories,
Ointment; Neomycin Division of Organics
Sulfate and Corp. of America,
Hydrocortisone 210 Orchard St.,
Acetate Ointment. East Rutherford, NJ
07073.
ANDA 060602............... Penicillin G John D. Copanos and
Potassium Powder. Co., Inc., 6110
Robinwood Rd.,
Baltimore, MD 21225.
ANDA 060627............... Tribiotic (polymyxin Ambix Laboratories,
B sulfate, Division of Organics
bacitracin, and Corp. of America.
neomycin sulfate)
Ointment, 5000 units/
400 units/5 mg.
ANDA 060724............... Pyocidin-HC (neomycin Kasco-EFCO
sulfate, polymyxin B Laboratories, Inc.,
sulfate, and Cantiague Rock Rd.,
hydrocortisone) Otic Hicksville, NY
Solution. 11802.
ANDA 060769............... Tetracycline Syrup... West-Ward
Pharmaceutical
Corp., 465
Industrial Way West,
Eatontown, NJ 07724.
ANDA 060773............... Tetracycline Syrup... Leiner Health
Products, Inc.
ANDA 060870............... Oxytetracycline Proter S.p.A., c/o
Injection. Richmar
International, Inc.,
1706 Birch Rd.,
McLean, VA 22101.
ANDA 061154............... Hydrocortisone Ambix Laboratories,
Acetate and Neomycin Division of Organics
Sulfate Ointment. Corp. of America.
ANDA 061209............... Bacitracin Ointment Do.
USP, 500 units/g.
ANDA 061228............... Griseofulvin Capsules Owen Laboratories,
Division of Alcon
Laboratories, 3737
Beltline Rd.,
Dallas, TX 75234.
ANDA 061483............... Penicillin G Leiner Health
Potassium Tablets. Products, Inc.
ANDA 061518............... Bacitracin Zinc Rexall Drug Co., 135
Ointment. Chesterfield
Industrial Blvd.,
Chesterfield, MO
63017.
ANDA 061519............... Bacitracin Zinc and Do.
Neomycin Sulfate
Ointment.
ANDA 061520............... Bacitracin Zinc and Do.
Neomycin Sulfate/
Polymyxin B Sulfate
Ointment.
ANDA 061521............... Bacitracin Zinc, Do.
Benzocaine, and
Neomycin Sulfate/
Polymyxin B Sulfate
Ointment.
ANDA 061528............... Penicillin V American Antibiotics,
Potassium Tablets Inc., 6110 Robinwood
USP, EQ 250 mg base Rd., Baltimore, MD
and EQ 500 mg base. 21225.
ANDA 061529............... Penicillin V Do.
Potassium for Oral
Solution USP, EQ 125
mg base/5 mL and EQ
250 mg base/5 mL.
ANDA 061532............... Ampicillin Trihydrate Leiner Health
Capsules. Products, Inc.
ANDA 061601............... Ampicillin for Oral American Antibiotics,
Suspension USP, EQ Inc.
125 mg base/5 mL and
EQ 250 mg base/5 mL.
ANDA 061602............... Ampicillin Capsules Do.
USP, EQ 250 mg base
and EQ 500 mg base.
ANDA 061632............... Ampicillin Trihydrate Chromalloy
Capsules, 250 mg. Pharmaceuticals,
Inc., 5353 Grosvenor
Blvd., Los Angeles,
CA 90066.
ANDA 061674............... Penicillin V Leiner Health
Potassium Tablets. Products, Inc.
ANDA 061697............... Griseofulvin Capsules Watson Laboratories,
Inc., 311 Bonnie
Cir., Corona, CA
92880.
ANDA 061699............... Bacitracin Powder for Apothekernes
Rx Compounding, Laboratorium A.S., c/
5,000,000 units/ o AL Laboratories,
bottle. Inc., 1 Executive
Dr., Fort Lee, NJ
07024.
ANDA 061833............... Oxytetracycline HCl Pliva, c/o Transtrade
Capsules, 250 mg. USA, Ltd., 515
Madison Ave., 4th
Floor East, New
York, NY 10022.
ANDA 061847............... Bleomycin Sulfate Takasaki Plant,
Injection. Nippon Kayaku Co.,
Ltd., 500 5th Ave.,
Suite 1726, New
York, NY 10110.
[[Page 58678]]
ANDA 061857............... Penicillamine Powder. Chemiewerk Homberg, c/
o Wallace
Laboratories,
Cranbury, NJ 08512.
ANDA 061903............... Bacitracin Zinc and Ambix Laboratories,
Polymyxin B Sulfate Division of Organics
Ointment. Corp. of America.
ANDA 062085............... Tetracycline HCl MM Mast and Co., 4152
Capsules, 250 mg. Ruple Rd.,
Cleveland, OH 44121.
ANDA 062205............... Cefaclor Capsules Ceph International
USP, EQ 250 mg base Corp. c/o Mova
and EQ 500 mg base. Pharmaceutical
Corp., State Rd. #1,
Jose Garrido St.,
Cagus, PR 00725.
ANDA 062340............... Gentamicin Sulfate Pharmaceutical
Injection. Specialist
Association, 9852
Cowden St.,
Philadelphia, PA
19115.
ANDA 062467............... E-Solve 2 Syosset Laboratories,
(erythromycin) Inc., 150 Eileen
Lotion, 2%. Way, Syosset, NY
11791.
ANDA 062758............... Eryzole (erythromycin Alra Laboratories,
ethylsuccinate and Inc., 3850 Clearview
sulfisoxazole Ct., Gurnee, IL
acetyl) Granules, EQ 60031.
200 mg base/5 mL; EQ
600 mg base/5 mL.
ANDA 062944............... Clindamycin Phosphate BOCA Pharmacal, LLC.,
Topical Solution 3550 North West
USP, EQ 1% base. 126th Ave., Coral
Springs, FL 33065.
ANDA 070104............... Chlorhexidine Matrix Medical Corp.,
Gluconate Topical 1825 South 3730
Solution, 4%. West, Salt Lake
City, UT 84104.
ANDA 071054............... Constilac (lactulose) Alra Laboratories,
Solution, 10 g/15 mL. Inc.
ANDA 071057............... Ibu-tab 200 Do.
(ibuprofen) Tablets,
200 mg.
ANDA 071058............... Ibu-tab (ibuprofen) Do.
Tablets, 400 mg.
ANDA 071059............... Ibu-tab (ibuprofen) Do.
Tablets, 600 mg.
ANDA 071104............... Leucovorin Calcium Xanodyne Pharmacal,
Tablets, EQ 15 mg Inc., 7310 Turfway
base. Rd., Suite 490,
Florence, KY 41042.
ANDA 071139............... Trazodone HCl American
Tablets, 50 mg. Therapeutics, Inc.,
89 Carlough Rd.,
Bohemia, NY 11716.
ANDA 071140............... Trazodone HCl Do.
Tablets, 100 mg.
ANDA 071331............... Cholac (lactulose) Alra Laboratories,
Solution, 10 g/15 mL. Inc.
ANDA 071362............... Meclofenamate Sodium American
Capsules USP, 50 mg. Therapeutics, Inc.
ANDA 071363............... Meclofenamate Sodium Do.
Capsules USP, 100 mg.
ANDA 071419............... Brian Care Soapco, Inc., P.O.
(chlorhexidine Box 5490,
gluconate) Topical Pleasanton, CA
Solution, 4%. 94566.
ANDA 071429............... Clorazepate American
Dipotassium Therapeutics, Inc.
Capsules, 3.75 mg.
ANDA 071430............... Clorazepate Do.
Dipotassium
Capsules, 7.5 mg.
ANDA 071431............... Clorazepate Do.
Dipotassium
Capsules, 15 mg.
ANDA 071569............... Danazol Capsules USP, Do.
200 mg.
ANDA 071787............... Gen-Xene (clorazepate Alra Laboratories,
dipotassium) Inc.
Tablets, 3.75 mg.
ANDA 071788............... Gen-Xene (clorazepate Do.
dipotassium)
Tablets, 7.5 mg.
ANDA 071789............... Gen-Xene (clorazepate Do.
dipotassium)
Tablets, 15 mg.
ANDA 071955............... Oxazepam Capsules American
USP, 10 mg. Therapeutics, Inc.
ANDA 071956............... Oxazepam Capsules Do.
USP, 15 mg.
ANDA 071957............... Oxazepam Capsules Do.
USP, 30 mg.
ANDA 071962............... Leucovorin Calcium Xanodyne Pharmacal,
Tablets, EQ 10 mg Inc.
base.
ANDA 071965............... Ibu-tab (ibuprofen) Alra Laboratories,
Tablets, 800 mg. Inc.
ANDA 072022............... Triamterene and American
Hydrochlorothiazide Therapeutics, Inc.
Tablets, 75 mg/50 mg.
ANDA 072129............... Maprotiline HCl Do.
Tablets USP, 25 mg.
ANDA 072130............... Maprotiline HCl Do.
Tablets USP, 50 mg.
ANDA 072131............... Maprotiline HCl Do.
Tablets USP, 75 mg.
ANDA 072190............... Metaproterenol Wockhardt EU
Sulfate Inhalation Operations (Swiss)
Solution, 5%. AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 072255............... Microderm Johnson and Johnson
(chlorhexidine Medical, Inc., 2500
gluconate) Topical Arbrook Blvd.,
Solution, 4%. Arlington, TX 76014.
ANDA 072292............... Prevacare R Do.
(chlorhexidine
gluconate) Topical
Solution, 0.5%.
ANDA 072295............... Microderm Do.
(chlorhexidine
gluconate) Topical
Sponge, 4%.
ANDA 072307............... Fenoprofen Calcium American
Capsules USP, 200 mg. Therapeutics, Inc.
ANDA 072308............... Fenoprofen Calcium Do.
Capsules USP, 300 mg.
ANDA 072309............... Fenoprofen Calcium Do.
Tablets USP, 600 mg.
ANDA 072782............... Prazosin HCl Capsules Do.
USP, 1 mg.
ANDA 072783............... Prazosin HCl Capsules Do.
USP, 2 mg.
ANDA 072784............... Prazosin HCl Capsules Do.
USP, 5 mg.
ANDA 073535............... Piroxicam Capsules, Mutual Pharmaceutical
10 mg. Co., Inc., 1100
Orthodox St.,
Philadelphia, PA
19124.
ANDA 074523............... Metromidol Laboratorios
(metronidazole) Applicaciones
Tablets, 250 mg and Farmaceuticas S.A.
500 mg. de CV, c/o Richard
Hamer Association,
Inc., P.O. Box
16598, Fort Worth,
TX 76162.
ANDA 074560............... Flurbiprofen Tablets Theragen, Inc., 10
USP, 100 mg. Lake Dr., East
Windsor, NJ 08520.
ANDA 074702............... Metaproterenol Wockhardt EU
Sulfate Syrup, 10 mg/ Operations (Swiss)
5 mL. AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 074881............... Iopamidol Injection, Cook Imaging Corp.,
41%, 51%, 61%, and 927 South Curry
76%. Pike, P.O. Box 3068,
Bloomington, IN
47403.
ANDA 075181............... Prednisolone Sodium WE Pharmaceuticals,
Phosphate Oral Inc.
Solution, EQ 5 mg
base/5 mL.
[[Page 58679]]
ANDA 075260............... Tretinoin Topical Wockhardt EU
Solution, 0.05%. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 075414............... Nifedipine Extended- Martec USA, LLC, 1800
Release Tablets, 90 North Topping Ave.,
mg. Kansas City, MO
64120.
ANDA 075507............... Ipratropium Bromide Pharmascience, Inc.,
Inhalation Solution, 10 Orchard Pl.,
0.02%. Tenafly City, NJ
07670.
ANDA 075569............... Thallous Chloride TL Trace Life Sciences,
201 Injection USP, 1 Inc., 2101 Shady
mCi/mL. Oaks, Denton, TX
76205.
ANDA 075586............... Metaproterenol Wockhardt EU
Sulfate Inhalation Operations (Swiss)
Solution, 0.4% and AG, c/o Morton Grove
0.6%. Pharmaceuticals,
Inc.
ANDA 075619............... Minoxidil Extra Avacor Products, LLC,
Strength (for Men) 227 East 56th St.,
Topical Solution, 5%. 3rd Floor, New York,
NY 10022.
ANDA 075766............... Calcitriol Injection, Fresenius Medical
1 microgram (mcg)/mL Care North America,
and 2 mcg/mL. 95 Hayden Ave.,
Lexington, MA 02421.
ANDA 075941............... Strontium Chloride SR- Bio-Nucleonics, Inc.,
89 Injection, 1 mCi/ 1600 Market St.,
mL. Suite 13200,
Philadelphia, PA
19103.
ANDA 077072............... Ipratropium Bromide Landela
Inhalation Solution, Pharmaceutical, 776
0.02%. East Riverside Dr.,
Suite 150, Eagle, ID
83616.
ANDA 077218............... ThyroShield Arco Pharmaceuticals,
(potassium iodide) LLC, 7605 Maryland
Oral Solution USP, Ave., St. Louis, MO
65 mg/mL. 63105.
ANDA 077569............... Albuterol Sulfate Landela
Inhalation Solution, Pharmaceutical.
EQ 0.083% base.
ANDA 080024............... Sulfacel-15 Optopics Laboratories
(sulfacetamide Corp., P.O. Box 210,
sodium) Ophthalmic Fairton, NJ 08320.
Solution, 15%.
ANDA 080036............... Sosol (sulfisoxazole) MK Laboratories,
Tablets, 500 mg. Inc., 424 Grasmere
Ave., Fairfield, CT
06430.
ANDA 080366............... Soxazole Alra Laboratories,
(sulfisoxazole) Inc.
Tablets, 500 mg.
ANDA 080380............... Bamate (meprobamate) Do.
Tablets, 200 mg and
400 mg.
ANDA 080483............... Hi-cor C and M Pharmacal,
(hydrocortisone) Inc., 1519 East 8
Cream, 2.5%. Mile Rd., Hazel
Park, MI 48030.
ANDA 080492............... Reserpine Tablets, Marshall Pharmacal
0.1 mg and 0.25 mg. Corp., 89 Michael
St., South
Hackensack, NJ
07606.
ANDA 080518............... Dimenhydrinate Alra Laboratories,
Tablets, 50 mg. Inc.
ANDA 080519............... Diphenhydramine HCl Do.
Capsules, 25 mg and
50 mg.
ANDA 080525............... Reserpine Tablets, MK Laboratories, Inc.
0.1 mg and 0.25 mg.
ANDA 080592............... Diphenhydramine HCl Valeant
Capsules, 50 mg. Pharmaceuticals
International, One
Enterprise, Aliso
Viejo, CA 92656.
ANDA 080660............... Ocusulf Miza Pharmaceuticals
(sulfacetamide USA, Inc., c/o
sodium) Ophthalmic Optopics
Solution, 10% and Laboratories, 40
30%. Main St., P.O. Box
210, Fairton, NJ
08320.
ANDA 080714............... Diphenhydramine HCl Alra Laboratories,
Oral Solution, 12.5 Inc.
mg/5 mL.
ANDA 080715............... Dimenhydrinate Oral Do.
Solution, 12.5 mg/4
mL.
ANDA 080941............... Isoniazid Tablets, MK Laboratories, Inc.
100 mg.
ANDA 080970............... Methscopolamine Private Formulations,
Bromide Tablets, 2.5 Inc., 460 Plainfield
mg. Ave., Edison, NJ
08818.
ANDA 083087............... Diphenhydramine HCl MK Laboratories, Inc.
Capsules, 25 mg and
50 mg.
ANDA 083088............... Diphenhydramine HCl Do.
Elixir, 12.5 mg/5 mL.
ANDA 083264............... Pentobarbital Sodium Valeant
Capsules, 100 mg. Pharmaceuticals
International.
ANDA 083286............... Chlorpheniramine Marshall Pharmacal
Maleate Tablets. Corp.
ANDA 083315............... Procaine HCl Elkins Sinn
Injection, 1% and 2%. Pharmaceutical Co.,
c/o ESI Lederle, 2
Esterbrook Ln.,
Cherry Hill, NJ
08003.
ANDA 083320............... Acetazolamide Alra Laboratories,
Tablets, 250 mg. Inc.
ANDA 083389............... Epinephrine and Dell Laboratories,
Lidocaine HCl Inc., 668 Front St.,
Injection, 0.01 mg/ Teaneck, NJ 07666.
mL and 1%.
ANDA 083390............... Epinephrine and Do.
Lidocaine HCl
Injection, 0.01 mg/
mL and 2%.
ANDA 083457............... Vitamin A Palmitate MK Laboratories, Inc.
Capsules, EQ 25,000
units base and EQ
50,000 units base.
ANDA 083524............... Butabarbital Sodium Marshall Pharmacal
Tablets, 16.2 mg. Corp.
ANDA 083525............... Niacin Tablets, 500 MK Laboratories, Inc.
mg.
ANDA 083526............... Folic Acid Tablets, 1 Do.
mg.
ANDA 083658............... Promethazine HCl Private Formulations,
Tablets, 25 mg. Inc.
ANDA 083806............... Dexamethasone Phoenix Laboratories,
Tablets, 0.75 mg. Inc., 175 Lauman
Ln., East
Hicksville, NY
11801.
ANDA 083827............... Pramine (imipramine Alra Laboratories,
HCl) Tablets, 10 mg, Inc.
25 mg, and 50 mg.
ANDA 083858............... Butabarbital Sodium Marshall Pharmacal
Tablets, 32.4 mg. Corp.
ANDA 083863............... Sulfisoxazole Cream.. Holland Rantos Co.,
Inc., P.O. Box 385,
Piscataway, NJ
08854.
ANDA 084185............... Bethanechol Chloride Wendt Laboratories,
Tablets, 10 mg. Inc., 200 West
Beaver, P.O. Box
128, Belle Plaine,
MN 56011.
ANDA 084186............... Bethanechol Chloride Do.
Tablets, 25 mg.
ANDA 084188............... Myotonachol Glenwood, Inc., 83
(bethanechol North Summit St.,
chloride) Tablets, 5 P.O. Box 518,
mg, 10 mg, and 25 mg. Tenafly, NJ 07670.
[[Page 58680]]
ANDA 084246............... Cortisone Acetate Everylife, 2021 15th
Tablets, 25 mg. Ave., West Seattle,
WA 98119.
ANDA 084439............... Prednisolone Tablets, Do.
1 mg, 2.5 mg, and 5
mg.
ANDA 084440............... Prednisone Tablets, 1 Do.
mg, 2.5 mg, and 5 mg.
ANDA 084494............... Hydrochlorothiazide West-Ward
Tablets. Pharmaceutical Corp.
ANDA 084590............... Pentobarbital Sodium Anabolic, Inc., 1835
Capsules, 100 mg. East Cheyenne Rd.,
Colorado Springs, CO
80905.
ANDA 084687............... Niacin Tablets, 500 Zzeon
mg. Pharmaceuticals,
Ltd., Jamboree at
Kevin, Irvine, CA
92705.
ANDA 084714............... Hydro-Reserp ABC Holding Corp.,
(hydrochlorothiazide P.O. Box 307, 70945
and reserpine) Van Dyke Ave.,
Tablets, 50 mg/0.125 Romeo, MI 48065.
mg.
ANDA 084729............... Lidocaton Pharmaton, Ltd., c/o
(epinephrine and Bass Ullmna and
lidocaine HCl) Lustigman, 747 3rd
Injection, 0.01 mg/ Ave., New York, NY
mL and 2%. 10017.
ANDA 084872............... Meclizine HCl CM Bundy Co., 2055
Tablets, 25 mg. Reading Rd.,
Cincinnati, OH
45205.
ANDA 084902............... Promethacon Polymedica
(promethazine HCl) Industries, Inc., 2
Suppository, 50 mg. Constitution Way,
Woburn, MA 01801.
ANDA 084931............... Methamphetamine HCl Rexar Pharmacal, 396
Tablets, 5 mg and 10 Rockaway Ave.,
mg. Valley Stream, NY
11581.
ANDA 084933............... Diethylstilbestrol West-Ward
Tablets, 1 mg. Pharmaceutical Corp.
ANDA 084977............... Halothane Inhalation, BH Chemicals, Inc.,
99.99%. 500 5th Ave., New
York, NY 10036.
ANDA 085009............... Lygen Alra Laboratories,
(chlordiazepoxide Inc.
HCl) Capsules, 10 mg.
ANDA 085039............... Folic Acid Tablets Wendt Laboratories,
USP, 1 mg. Inc.
ANDA 085040............... Isoniazid Tablets Do.
USP, 100 mg.
ANDA 085041............... Meclizine HCl Do.
Tablets, 25 mg.
ANDA 085042............... Methocarbamol Tablets Do.
USP, 500 mg.
ANDA 085044............... Reserpine Tablets Do.
USP, 0.25 mg.
ANDA 085075............... Aerolate III Fleming and Co.
(theophylline) Pharmaceuticals,
Extended-Release Inc., 1600 Fenton
Capsules, 65 mg. Park Dr., Fenton, MO
Aerolate JR 63026.
(theophylline)
Extended-Release
Capsules, 130 mg.
Aerolate SR
(theophylline)
Extended-Release
Capsules, 260 mg.
ANDA 085107............... Lygen Alra Laboratories,
(chlordiazepoxide Inc.
HCl) Capsules, 5 mg.
ANDA 085108............... Lygen Do.
(chlordiazepoxide
HCl) Capsules, 25 mg.
ANDA 085125............... Methyltestosterone Tablicaps, Inc., P.O.
Sublingual Tablets, Box 5555,
10 mg. Franklinville, NJ
08322.
ANDA 085235............... Chlordiazepoxide HCl Abbott Laboratories,
Capsules. Pharmaceutical
Products Division,
100 Abbott Park Rd.,
Abbott Park, IL
60064.
ANDA 085236............... Chlordiazepoxide HCl Do.
Capsules.
ANDA 085252............... Meclizine HCl ABC Holding Corp.
Tablets, 25 mg.
ANDA 085253............... Meclizine HCl Do.
Tablets, 12.5 mg.
ANDA 085282............... Hydrocortisone Mericon Industries,
Lotion, 0.5% and 1%. Inc., 8819 North
Pioneer Rd., Peoria,
IL 61615.
ANDA 085383............... Butabarbital Sodium Wockhardt EU
Elixir, 30 mg/5 mL. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 085411............... Phentermine HCl ABC Holding Corp.
Capsules, 30 mg.
ANDA 085511............... Cam-Metrazine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 085512............... Phenazine-35 Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 085550............... Butabarbital Sodium CM Bundy Co.
Tablets, 30 mg.
ANDA 085569............... Chlorothiazide ABC Holding Corp.
Tablets, 250 mg.
ANDA 085587............... Meclizine HCl Camall Co., Inc.,
Chewable Tablets. 60950 Van Dyke Ave.,
P.O. Box 218,
Washington, MI
48094.
ANDA 085672............... Hydrochlorothiazide ABC Holding Corp.
Tablets, 50 mg.
ANDA 085756............... Cam-Metrazine Camall Co., Inc.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 085766............... Atropine Sulfate and Private Formulations,
Diphenoxylate HCl Inc.
Tablets, 0.025 mg/
2.5 mg.
ANDA 085888............... Brompheniramine Leiner Health
Maleate Tablets. Products, Inc.
ANDA 085891............... Meclizine HCl Anabolic, Inc.
Tablets, 25 mg.
ANDA 085895............... Secobarbital Sodium Everylife.
Capsules, 100 mg.
ANDA 086008............... Hydrocortisone and Bioglan Laboratories,
Urea Cream, 1%/10%. Ltd., 450 Hilltop
Rd., Riegelsville,
PA 18077.
ANDA 086077............... Nitrofurazone Ambix Laboratories,
Ointment, 0.2%. Division of Organics
Corp. of America.
ANDA 086079............... Hydrocortisone Do.
Ointment, 1%.
ANDA 086080............... Hydrocortisone Cream, Do.
1%.
ANDA 086141............... Tolbutamide Tablets, Alra Laboratories,
500 mg. Inc.
ANDA 086260............... Ona-Mast (phentermine MM Mast and Co.
HCl) Tablets, 8 mg.
ANDA 086271............... Hydrocortisone Cream, Ambix Laboratories,
2.5%. Division of Organics
Corp. of America.
ANDA 086272............... Hydrocortisone Do.
Ointment, 2.5%.
ANDA 086498............... Amitriptyline HCl Alra Laboratories,
Tablets, 10 mg. Inc.
ANDA 086499............... Amitriptyline HCl Do.
Tablets, 50 mg.
ANDA 086500............... Amitriptyline HCl Do.
Tablets, 150 mg.
ANDA 086501............... Amitriptyline HCl Do.
Tablets, 100 mg.
ANDA 086502............... Amitriptyline HCl Do.
Tablets, 25 mg.
ANDA 086503............... Amitriptyline HCl Do.
Tablets, 75 mg.
[[Page 58681]]
ANDA 086511............... Ona-Mast (phentermine MM Mast and Co.
HCl) Capsules, 30 mg.
ANDA 086516............... Ona-Mast (phentermine Do.
HCl) Capsules, 30 mg.
ANDA 086550............... X-Trozine Shire Richwood, Inc.,
(phendimetrazine 7900 Tanners Gate
tartrate) Tablets, Dr., Suite 200,
35 mg. Florence, KY 41042.
ANDA 086551............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086552............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086553............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086554............... X-Trozine Do.
(phendimetrazine
tartrate) Tablets,
35 mg.
ANDA 086735............... Phentermine HCl Camall Co., Inc.
Capsules, 15 mg.
ANDA 086748............... Theophylline Elixir, Wockhardt EU
80 mg/15 mL. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
ANDA 086766............... Nitrofurazone Wendt Laboratories,
Ointment, 0.2%. Inc.
ANDA 087081............... Nitrofurazone Topical Do.
Solution, 0.2%.
ANDA 087226............... Phentermine HCl Camall Co., Inc.
Capsules, 30 mg.
ANDA 087371............... X-Trozine L.A. Shire Richwood, Inc.
(phendimetrazine
tartrate) Extended-
Release Capsules,
105 mg.
ANDA 087392............... Aminophylline Pharma Serve, Inc.,
Injection, 25 mg/mL. Subsidiary of
Torigian
Laboratories, 218-20
98th Ave., Queens
Village, NY 11429.
ANDA 087394............... X-Trozine Shire Richwood, Inc.
(phendimetrazine
tartrate) Capsules,
35 mg.
ANDA 087442............... Neosar Bedford Laboratories,
(cyclophosphamide) Division of Ben
for Injection, 100 Venue Laboratories,
mg/vial, 200 mg/ Inc., 300 Northfield
vial, 500 mg/vial, 1 Rd., Bedford, OH
g/vial, and 2 g/vial. 44146.
ANDA 087487............... Melfiat-105 Numark Laboratories,
(phendimetrazine Inc., 75 Mayfield
tartrate) Extended- Ave., Edison, NJ
Release Capsules, 08837.
105 mg.
ANDA 087636............... Tropicamide Miza Pharmaceuticals
Ophthalmic Solution, USA, Inc., c/o
0.5%. Optopics
Laboratories.
ANDA 087637............... Tropicamide Do.
Ophthalmic Solution,
1%.
ANDA 087681............... Paracaine Optopics Laboratories
(proparacaine HCl) Corp.
Ophthalmic Solution,
0.5%.
ANDA 087764............... Oby-Trim (phentermine Shire Richwood, Inc.
HCl) Capsules, 30 mg.
ANDA 087932............... Triamcinolone Ambix Laboratories,
Acetonide Cream, Division of Organics
0.025%. Corp. of America.
ANDA 088786............... Sodium Polystyrene Wockhardt EU
Sulfonate USP Operations (Swiss)
Powder, 453.6 g/ AG, c/o Morton Grove
bottle. Pharmaceuticals,
Inc.
ANDA 088897............... Promethazine VC Plain Do.
(phenylephrine HCl
and promethazine
HCl) Syrup, 5 mg/5
mL and 6.25 mg/5 mL.
ANDA 089141............... Aerolate Fleming and Co.
(theophylline) Oral Pharmaceuticals,
Solution, 150 mg/15 Inc.
mL.
ANDA 089417............... Methocarbamol Tablets American
USP, 500 mg. Therapeutics, Inc.
ANDA 089418............... Methocarbamol Tablets Do.
USP, 750 mg.
ANDA 089478............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
15 mg.
ANDA 089479............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
30 mg.
ANDA 089480............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
60 mg.
ANDA 089514............... Trihexyphenidyl HCl Pharmaceutical
Elixir, 2 mg/5 mL. Ventures, Ltd., P.O.
Box D3700, Pomona,
NY 10970.
ANDA 089726............... Prednisone Oral Wockhardt EU
Solution, 5 mg/5 mL. Operations (Swiss)
AG, c/o Morton Grove
Pharmaceuticals,
Inc.
------------------------------------------------------------------------
FDA finds that the holders of the ANDAs listed in table 1 have
repeatedly failed to submit reports required by Sec. Sec. 314.81 and
314.98. In addition, under Sec. 314.200, FDA finds that the holders of
the ANDAs have waived any contentions concerning the legal status of
the drug products. Therefore, under these findings, approval of the
ANDAs listed in table 1 and all amendments and supplements thereto, is
hereby withdrawn, effective October 22, 2021.
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23075 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on October 22, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.