Details for New Drug Application (NDA): 076633
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NDA 076633 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, Respirent Pharms, and Teva Pharms Usa, and is included in twenty-five NDAs. It is available from sixty-nine 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.
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 076633
| Tradename: | FLUTICASONE PROPIONATE |
| Applicant: | Encube |
| Ingredient: | fluticasone propionate |
| Patents: | 0 |
Pharmacology for NDA: 076633
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076633
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 076633 | ANDA | Encube Ethicals, Inc. | 21922-075 | 21922-075-04 | 1 TUBE in 1 CARTON (21922-075-04) / 15 g in 1 TUBE |
| FLUTICASONE PROPIONATE | fluticasone propionate | CREAM;TOPICAL | 076633 | ANDA | Encube Ethicals, Inc. | 21922-075 | 21922-075-05 | 1 TUBE in 1 CARTON (21922-075-05) / 30 g in 1 TUBE |
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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