Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#acetaminophen ×
Actualizaciones regulatorias
5 sept 2026•1 min de lectura
FDA Approves ANDA085964 for Acetaminophen and Codeine Phosphate Tablet
The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Approves KV PHARM Acetaminophen/Codeine Phosphate Tablet (ANDA085288)
FDA approved KV PHARM's oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate (ANDA085288). Multiple labeling submissions were filed; the product is now discontinued.
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Actualizaciones regulatorias
28 ago 2026•1 min de lectura
FDA Approves Multiple Submissions for LORTAB (ANDA 087722)
The FDA’s ANDA 087722 for LORTAB (acetaminophen 500 mg/hydrocodone 5 mg oral tablet) includes a series of approved manufacturing and labeling submissions from 1984 to 1999; the product is now discontinued.