규제 업데이트
2026년 9월 12일•1분 읽기
Teva Pharm’s Simvastatin Tablet ANDA 076532 Receives Tentative FDA Approval
The FDA granted tentative approval to Teva Pharm’s generic simvastatin tablets (5‑80 mg) under ANDA 076532.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves Oxford Pharm Generic Simvastatin Tablets (ANDA078735)
FDA has approved Oxford Pharm's abbreviated new drug application for generic simvastatin tablets in five strengths, all prescription oral products.
규제 업데이트
2026년 9월 8일•1분 읽기
FDA Approves ANDA077766 for Simvastatin Generic Tablets
The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.
규제 업데이트
2026년 9월 3일•1분 읽기
FDA Approves Multiple Simvastatin Tablet Labeling Submissions (ANDA 077752)
The FDA has approved several labeling submissions for generic oral Simvastatin tablets (5‑80 mg) under ANDA 077752, confirming their prescription status.