Details for New Drug Application (NDA): 076504
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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 076504
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Hikma |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076504
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076504
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 076504 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3270 | 0054-3270-99 | 1 BOTTLE, GLASS in 1 CARTON (0054-3270-99) / 120 SPRAY, METERED in 1 BOTTLE, GLASS |
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 076504 | ANDA | A-S Medication Solutions | 50090-2880 | 50090-2880-0 | 1 BOTTLE, GLASS in 1 CARTON (50090-2880-0) / 120 SPRAY, METERED in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
Approval Date: | Feb 22, 2006 | TE: | AB | RLD: | No |
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