Details for New Drug Application (NDA): 077055
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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 077055
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Cosette |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077055
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 077055
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 077055 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0631 | 0713-0631-15 | 1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE |
FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 077055 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0631 | 0713-0631-31 | 1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jun 30, 2006 | TE: | AB | RLD: | No |
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