Last Updated: June 2, 2026

Details for New Drug Application (NDA): 090759

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NDA 090759 describes FLUTICASONE PROPIONATE, which is a drug marketed by Glenmark Speclt, 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, Respirent Pharms, and Teva Pharms Usa, and is included in twenty-seven NDAs. It is available from seventy 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. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for 090759

Tradename:	FLUTICASONE PROPIONATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	fluticasone propionate
Patents:	0

Pharmacology for NDA: 090759

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 090759

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUTICASONE PROPIONATE	fluticasone propionate	LOTION;TOPICAL	090759	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-427	68462-427-02	1 BOTTLE in 1 CARTON (68462-427-02) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	LOTION;TOPICAL			Strength	0.05%
Approval Date:	May 2, 2011	TE:		RLD:	No

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