Federal Register #FDA-2025-P-1372

FDA determination on PHENAPHEN WITH CODEINE NO. 3 and NO. 4 oral capsules eligibility for generic approval

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a determination regarding PHENAPHEN WITH CODEINE NO. 3 and NO. 4 oral capsules. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Wyeth-Ayerst Laboratories (original manufacturer) - LGM Pharma Solutions, LLC (petition submitter) - Products/Services Requested: - PHENAPHEN WITH CODEINE NO. 3 oral capsules (acetaminophen 325 mg; codeine phosphate 30 mg) - PHENAPHEN WITH CODEINE NO. 4 oral capsules (acetaminophen 325 mg; codeine phosphate 60 mg) - No specific quantities or part numbers provided - Unique/Notable Requirements: - FDA determined these products were not withdrawn for safety or effectiveness reasons - Allows approval of generic versions (ANDAs) if all legal and regulatory requirements are met - Products remain listed in the FDA Orange Book Discontinued Drug Product List - Indicated for relief of mild to moderately severe pain

Description

The Food and Drug Administration (FDA) has determined that PHENAPHEN WITH CODEINE NO. 3 and NO. 4 oral capsules were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for these capsules if all other legal and regulatory requirements are met. The capsules are indicated for relief of mild to moderately severe pain. The determination was made after reviewing a citizen petition and agency records, finding no evidence of withdrawal for safety or effectiveness reasons.

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