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Product safetyFDAUnited StatesImports

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WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

3 September 2026

In plain English

FDA determined that PHENAPHEN WITH CODEINE NO. 3 and NO. 4 (acetaminophen; codeine phosphate) oral capsules were not withdrawn for safety or effectiveness reasons, permitting approval of ANDAs referencing them.

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Topic
Product safety
Regulator
FDA
Published
3 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 phos
The full text is at the source

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