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FDA ANDA 207957, FLUTICASONE PROPIONATE, HIKMA, 05/26/2016

FDA ANDA 207957, FLUTICASONE PROPIONATE, HIKMA, 05/26/2016

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Contents: Summary Basis of Approval (SBA) for Fluticasone Propionate Nasal Spray, 50mcg/Spray for ANDA 76504 and ANDA 207957 (HIKMA PHARMACEUTICALS USA INC)

ANDA: 207957
Company: HIKMA
Drug Name: FLUTICASONE PROPIONATE
Active Ingredients: FLUTICASONE PROPIONATE
Strength: 0.05MG/SPRAY
Dosage Form/Route: SPRAY, METERED;NASAL
Action Date: 05/26/2016
Marketing Status: Over-the-counter
Submission Classification: ORIG-1
Action Date: None

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