Details for New Drug Application (NDA): 219602
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NDA 219602 describes FLUTICASONE PROPIONATE, which is a drug marketed by Glenmark Speclt, 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-seven NDAs. It is available from seventy 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 219602
| Tradename: | FLUTICASONE PROPIONATE |
| Applicant: | Glenmark Speclt |
| Ingredient: | fluticasone propionate |
| Patents: | 0 |
Pharmacology for NDA: 219602
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 219602
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | fluticasone propionate | AEROSOL, METERED;INHALATION | 219602 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-937 | 68462-937-20 | 1 INHALER in 1 CARTON (68462-937-20) / 120 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.044MG/INH | ||||
| Approval Date: | Mar 3, 2026 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Sep 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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