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FDA approval · 2023-12-15

FDA Approved: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York, LLC)

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Summary

The FDA approved a supplemental application for Amneal's fixed-dose combination product of butalbital, aspirin, caffeine and codeine phosphate, supporting modif…

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Diseases / indications

Drugs mentioned

  • Butalbital, Aspirin, Caffeine and Codeine Phosphate (Butalbital; Acetylsalicylic acid; Caffeine; Codeine phosphate)

Snippet

SUPPL AP for BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE)