Notice2025-22681
Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
December 12, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
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[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Notices]
[Pages 57768-57770]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4734]
Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100
Milligrams, and Other Drug Products Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#782b0c191b01563319161d381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="f6a58297958fd8bd979893b6909297d89e9e85d8919980">[email protected]</span></a>.
[[Page 57769]]
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
generally known as the ``Orange Book.'' Under FDA regulations, a drug
is removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness, or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in table 1 are
no longer being marketed.
Table 1--Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 005010............ DEMEROL......... Meperidine 100 Milligrams Tablet; Oral.... Quagen
Hydrochloride. (mg). Pharmaceuticals
LLC.
NDA 009402............ DELESTROGEN..... Estradiol 40 mg/Milliliter Injectable; Endo Operations
Valerate. (mL). Injection. Ltd.
NDA 011338............ FLUOTHANE....... Halothane....... 99.99%.......... Liquid; Wyeth-Ayerst
Inhalation. Laboratories.
NDA 017354............ LOESTRIN FE 1/20 Ethinyl 0.02 mg, 1 mg... Tablet; Oral.... Teva Branded
Estradiol, Pharmaceutical
Norethindrone Products R&D
Acetate. Inc.
NDA 018063............ CORGARD......... Nadolol......... 20 mg; 40 mg; 80 Tablet; Oral.... US WorldMeds,
mg. LLC.
NDA 019429............ FIORINAL W/ Aspirin, 325 mg, 50mg, 40 Capsule; Oral... Allergan.
CODEINE. Butalbital, mg, 30mg.
Caffeine,
Codeine
Phosphate.
NDA 019758............ CLOZARIL........ Clozapine....... 50 mg; 200 mg... Tablet; Oral.... Heritage Life
Sciences
Barbados Inc.
NDA 020496............ AMARYL.......... Glimepiride..... 1 mg; 2 mg; 4 mg Tablet; Oral.... Sanofi-Aventis
U.S. LLC.
NDA 020768............ ZOMIG........... Zolmitriptan.... 2.5 mg; 5 mg.... Tablet; Oral.... IPR
Pharmaceuticals
, Inc.
NDA 020933............ VIRAMUNE........ Nevirapine...... 50 mg/5 mL...... Suspension; Oral Boehringer
Ingelheim
Pharmaceuticals
Inc.
NDA 021123............ ULTRACET........ Acetaminophen, 325 mg, 37.5 mg. Tablet; Oral.... Janssen
Tramadol Pharmaceuticals
Hydrochloride. Inc.
NDA 021142............ OLUX............ Clobetasol 0.05%........... Aerosol, Foam; Norvium
Propionate. Topical. Bioscience,
LLC.
NDA 021231............ ZOMIG-ZMT....... Zolmitriptan.... 2.5 mg; 5 mg.... Orally AstraZeneca
Disintegrating Pharmaceuticals
Tablet; Oral. LP.
NDA 021368............ CIALIS.......... Tadalafil....... 2.5 mg.......... Tablet; Oral.... Eli Lilly and
Co.
NDA 021497............ ALINIA.......... Nitazoxanide.... 500 mg.......... Tablet; Oral.... Romark
Laboratories.
NDA 021636............ ZEGERID......... Omeprazole, 20 mg/Packet, For Suspension; Salix
Sodium 1.68 grams (g)/ Oral. Pharmaceuticals
Bicarbonate. Packet; 40 mg/ Inc.
Packet, 1.68 g/
Packet.
NDA 021689............ NEXIUM IV....... Esomeprazole EQ 40 mg Base/ Injectable; AstraZeneca
Sodium. Vial. Intravenous. Pharmaceuticals
LP.
NDA 021799............ QUALAQUIN....... Quinine Sulfate. 324 mg.......... Capsule; Oral... Sun
Pharmaceutical
Industries,
Inc.
NDA 021937............ ATRIPLA......... Efavirenz, 600 mg, 200 mg, Tablet; Oral.... Gilead Sciences,
Emtricitabine, 300 mg. Inc.
Tenofovir
Disoproxil
Fumarate.
NDA 021963............ ALLEGRA......... Fexofenadine 30 mg/5 mL...... Suspension; Oral Chattem Inc.,
Hydrochloride. DBA Sanofi
Consumer
Healthcare.
NDA 022331............ KAPVAY.......... Clonidine 0.1 mg.......... Extended-Release Concordia
Hydrochloride. Tablet; Oral. Pharmaceuticals
, Inc.
NDA 022352............ COLCRYS......... Colchicine...... 0.6 mg.......... Tablet; Oral.... Takeda
Pharmaceuticals
USA, Inc.
NDA 050682............ COSMEGEN........ Dactinomycin.... 0.5 mg/Vial..... Injectable; Recordati Rare
Injection. Diseases Inc.
NDA 050717............ MONUROL......... Fosfomycin EQ 3 g Base/ For Solution; Zambon Company
Tromethamine. Packet. Oral. S.p.A.
ANDA 086162........... BUTALBITAL, Aspirin, 325 mg, 50 mg, Tablet; Oral.... Hikma
ASPIRIN AND Butalbital, 40 mg. International
CAFFEINE. Caffeine. Pharmaceuticals
LLC.
ANDA 087056........... CYPROHEPTADINE Cyproheptadine 4 mg............ Tablet; Oral.... Avet
HYDROCHLORIDE. Hydrochloride. Pharmaceuticals
.
ANDA 088763........... PROMETHAZINE Codeine 10mg/5mL,....... Syrup; Oral..... Actavis Mid-
HYDROCHLORIDE Phosphate, 6.25mg/5mL...... Atlantic, LLC.
AND CODEINE Promethazine
PHOSPHATE. Hydrochloride.
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[[Page 57770]]
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
Approved ANDAs that refer to the drug products listed are
unaffected by the discontinued marketing of the products subject to
these applications. Additional ANDAs that refer to these products may
also be approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22681 Filed 12-11-25; 8:45 am]
BILLING CODE 4164-01-P
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