Details for New Drug Application (NDA): 078492
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NDA 078492 describes FLUTICASONE PROPIONATE, which is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Taro Pharm Inds, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from sixty-seven 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 078492
| Tradename: | FLUTICASONE PROPIONATE |
| Applicant: | Chartwell Rx |
| Ingredient: | fluticasone propionate |
| Patents: | 0 |
Pharmacology for NDA: 078492
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 078492
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 078492 | ANDA | RPK Pharmaceuticals, Inc. | 53002-7693 | 53002-7693-1 | 1 BOTTLE, SPRAY in 1 BOX (53002-7693-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY |
| FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 078492 | ANDA | Direct RX | 61919-004 | 61919-004-16 | 1 SPRAY, METERED in 1 BOX (61919-004-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
| Approval Date: | Jan 9, 2012 | TE: | AB | RLD: | No | ||||
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