Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met.

Full Text

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<title>Federal Register, Volume 91 Issue 170 (Thursday, September 3, 2026)</title>
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[Federal Register Volume 91, Number 170 (Thursday, September 3, 2026)]
[Notices]
[Pages 56654-56655]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-P-1372]


Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; 
Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and 
PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral 
Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From 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 PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine 
phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN 
WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 
325 mg and 60 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 
(acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and 
PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral 
capsules, 325 mg and 60 mg, if all other legal and regulatory 
requirements are met.

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#481b3c292b31660329262d082e2c296620203b662f273e"><span class="__cf_email__" data-cfemail="47143326243e690c26292207212326692f2f3469202831">[email&#160;protected]</span></a>.

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

[[Page 56655]]

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 
known generally as the ``Orange Book.'' Under FDA regulations, drugs 
are 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale but 
must be made prior to approving an ANDA that refers to the listed drug 
(Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does 
not refer to a listed drug.
    PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) 
oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 
(acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, are 
the subject of ANDAs 084445 and 084446, held by Wyeth-Ayerst 
Laboratories, and both initially approved on July 22, 1975. PHENAPHEN 
WITH CODEINE NO. 3 and PHENAPHEN WITH CODEINE NO. 4 are indicated for 
the relief of mild to moderately severe pain.
    In separate letters dated March 7, 2003, Wyeth-Ayerst requested 
withdrawal of ANDAs 084445 and 084446 for PHENAPHEN WITH CODEINE NO. 3 
(acetaminophen; codeine phosphate) and PHENAPHEN WITH CODEINE NO. 4 
(acetaminophen; codeine phosphate) in accordance with 21 CFR 
314.150(c). In the Federal Register of May 5, 2004 (69 FR 25124), FDA 
announced that it was withdrawing approval of ANDAs 084445 and 084446, 
effective June 4, 2004.
    LGM Pharma Solutions, LLC, submitted a citizen petition dated May 
16, 2025 (Docket No. FDA-2025-P-1372), under 21 CFR 10.30, requesting 
that the Agency determine whether PHENAPHEN WITH CODEINE NO. 3 
(acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and 
PHENAPHEN W CODEINE NO. 4 (acetaminophen; codeine phosphate) oral 
capsules, 325 mg and 60 mg, were voluntarily withdrawn from sale for 
reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; 
codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN W 
CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg 
and 60 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that PHENAPHEN WITH CODEINE NO. 3 
(acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and 
PHENAPHEN W CODEINE NO. 4 (acetaminophen; codeine phosphate) oral 
capsules, 325 mg and 60 mg, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of PHENAPHEN WITH CODEINE NO. 3 
(acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and 
PHENAPHEN W CODEINE NO. 4 (acetaminophen; codeine phosphate) oral 
capsules, 325 mg and 60 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
these drug products were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list PHENAPHEN WITH 
CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg 
and 30 mg, and PHENAPHEN W CODEINE NO. 4 (acetaminophen; codeine 
phosphate) oral capsules, 325 mg and 60 mg, in the ``Discontinued Drug 
Product List'' section of the Orange Book. The ``Discontinued Drug 
Product List'' delineates, among other items, drug products that have 
been discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs for these drug products may be approved by the 
Agency as long as they meet all other legal and regulatory requirements 
for the approval of ANDAs. 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.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18023 Filed 9-2-26; 8:45 am]
BILLING CODE 4164-01-P


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