法规动态

FDA、EMA、TGA 及全球法规动态

#codeine ×

2026年9月16日•1 分钟阅读

FDA Approves ANDA081095 for Oral Acetaminophen/Aspirin/Codeine Capsule (Discontinued)

The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.

2026年9月9日•1 分钟阅读

FDA Approves ANDA089479 for Acetaminophen/Codeine Phosphate Tablet (Discontinued)

The FDA granted approval for ANDA089479, submitted by AM THERAP, for an oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate. The product is listed as discontinued.

2026年9月8日•1 分钟阅读

FDA Discontinues PROVAL #3 Oral Capsule (ANDA085685)

FDA records show PROVAL #3 oral capsule, containing 325 mg acetaminophen and 30 mg codeine phosphate, is now discontinued. Sponsor: Solvay. ANDA085685.

2026年9月5日•1 分钟阅读

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.

2026年8月30日•1 分钟阅读

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.