Details for New Drug Application (NDA): 090759
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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 |
Formulation / Manufacturing: | see details |
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: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | May 2, 2011 | TE: | AB | RLD: | No |
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