Federal Register: FDA Rules Phenaphen With Codeine Was Not Withdrawn for Safety Concerns, Opening Path for Generic Applications
September 04, 2026
September 04, 2026
WASHINGTON, Sept. 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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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WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Eff . . .
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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WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Eff . . .