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2026-09-03 · Notice · Federal Register document 2026-18023

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WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Official 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30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.

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