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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 091553

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NDA 091553 describes FLUTICASONE PROPIONATE, which is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Chartwell Rx, Taro Pharm Inds, Apotex, Aurobindo Pharma Ltd, Hikma, Rubicon, Rubicon Research, and Teva Pharms Usa, and is included in twenty-four NDAs. It is available from sixty-eight suppliers. Additional details are available on the FLUTICASONE PROPIONATE profile page.

The generic ingredient in FLUTICASONE PROPIONATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for 091553

Tradename:	FLUTICASONE PROPIONATE
Applicant:	Padagis Israel
Ingredient:	fluticasone propionate
Patents:	0

Pharmacology for NDA: 091553

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 091553

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUTICASONE PROPIONATE	fluticasone propionate	LOTION;TOPICAL	091553	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-441	45802-441-02	60 mL in 1 BOTTLE (45802-441-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	0.05%
Approval Date:	Jul 30, 2013	TE:		RLD:	No

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