The U.S. Food and Drug Administration has granted approval to the Abbreviated New Drug Application (ANDA) number 077078 for metformin hydrochloride extended‑release tablets.
The product, listed under the brand name Metformin Hydrochloride, is a 750 mg oral tablet intended for prescription use. It is manufactured by Zydus Lifesciences Limited, with Viona Pharmaceuticals Inc. also identified as a manufacturer.
The FDA submission record shows the original application was filed on 2005‑04‑21 and subsequent labeling supplements have been approved, the most recent on 2026‑08‑11.
規制動向2026年9月15日•3分で読めます
FDA Approves ANDA077078 for Metformin Hydrochloride Extended‑Release Tablets
The FDA has approved the ANDA077078 application for metformin hydrochloride 750 mg extended‑release tablets marketed by Zydus Lifesciences.
Pharmacountryチームがまとめました · 出典： FDA.gov
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