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#Simvastatin ×

2026年9月12日•1分で読めます

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.

2026年9月9日•1分で読めます

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.

2026年9月8日•1分で読めます

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.

2026年9月3日•1分で読めます

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.