FDA ANDA 216935, PREDNISOLONE ACETATE, LUPIN LTD, 08/02/2024

Contents: Summary Basis of Approval of Bioequivalence Review for PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION 1% application A216935 approved on August 2, 2024 

ANDA: 216935
Company: LUPIN LTD
Drug Name: PREDNISOLONE ACETATE
Active Ingredients: PREDNISOLONE ACETATE
Strength: 1%
Dosage Form/Route: SUSPENSION/DROPS;OPHTHALMIC
Action Date: 08/02/2024
Marketing Status: Prescription
Submission Classification: ORIG-1

71 Pages