Details for New Drug Application (NDA): 076451
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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 076451
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Fougera Pharms |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Pharmacology for NDA: 076451
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076451
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 076451 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0332 | 0168-0332-15 | 15 g in 1 TUBE (0168-0332-15) |
FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 076451 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0332 | 0168-0332-30 | 30 g in 1 TUBE (0168-0332-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | May 14, 2004 | TE: | AB | RLD: | No |
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