Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Simvastatin ×
Actualizaciones regulatorias
12 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
8 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
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.