The U.S. Food and Drug Administration has approved application ANDA201251 submitted by Teva Pharm USA. The approval covers two injectable vancomycin hydrochloride products: a 500 mg per vial formulation (product number 001) and a 1 g per vial formulation (product number 002). Both products are listed with a marketing status of Discontinued.
The submission was classified as an original (ORIG) application, submission number 1, with an approval status (AP) recorded on December 23, 2015. The FDA issued a letter regarding the approval, which can be accessed at http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201251Orig1s000ltr.pdf.
Key details include the route of administration (injection), dosage form (injectable), and that neither product is designated as a reference drug or reference standard.
規制動向2026年9月16日•3分で読めます
FDA Approves ANDA201251 for Vancomycin Hydrochloride Injection
FDA approved ANDA201251 submitted by Teva Pharm USA for two vancomycin hydrochloride injectable products (500 mg and 1 g per vial), both listed as discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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