The U.S. Food and Drug Administration has granted approval for ANDA085288, an oral tablet formulation of acetaminophen 300 mg and codeine phosphate 30 mg, marketed by KV PHARM. The product, identified as "ACETAMINOPHEN AND CODEINE PHOSPHATE," was originally submitted on 23 July 1977 and received an approval status (AP). Subsequent labeling submissions were filed on 2 December 1988 (submission 44), 4 May 1988 (submission 43), and 8 October 1996 (submission 11). The tablet is listed as discontinued in the FDA database.
Key details:
- Route: Oral
- Dosage form: Tablet
- Product number: 001
- Marketing status: Discontinued
- Sponsor: KV PHARM
- Application number: ANDA085288
- Active ingredients: Acetaminophen 300 mg; Codeine phosphate 30 mg
규제 업데이트2026년 8월 30일•1분 읽기
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.
PharmaCountry 팀이 정리했습니다 · 출처: FDA.gov
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