Actualités réglementaires
5 sept. 2026•1 min de lecture
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.
Actualités réglementaires
30 août 2026•1 min de lecture
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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Actualités réglementaires
28 août 2026•1 min de lecture
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.