FDA ANDA 214348, BUPIVACAINE LIPOSOME, HENGRUI PHARMA, 07/01/2024

Contents: Summary Basis of Approval (or similar) for ANDA 214348 [Bupivacaine Liposome Injectable Suspension, 1.3% [133 mg/10 mL (13.3 mg/mL)] and 1.3% [266 mg/20 mL (13.3 mg/mL)] Single Dose Vials]

ANDA: 214348
Company: HENGRUI PHARMA
Drug Name: BUPIVACAINE LIPOSOME
Active Ingredients: BUPIVACAINE
Strength: 266MG/20ML (13.3MG/ML)
Dosage Form/Route: INJECTABLE, LIPOSOMAL;INJECTION
Action Date: 07/01/2024
Marketing Status: Prescription
Submission Classification: ORIG-1

6 Pages

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