The U.S. Food and Drug Administration has granted approval for ANDA214215, covering an injectable formulation of verapamil hydrochloride.
The product, marketed by Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited under the brand name Verapamil Hydrochloride, is a prescription human drug for intravenous administration. It is supplied at a strength of 2.5 mg/mL.
The original submission received standard review priority and was assigned an approval status on October 15, 2020. Multiple NDC codes are associated with the dosage form, which is classified as an injectable prescription medication.
規制動向2026年9月17日•3分で読めます
FDA Approves Zydus Verapamil Hydrochloride Injection (ANDA214215)
FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.
Pharmacountryチームがまとめました · 出典： FDA.gov
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