Details for New Drug Application (NDA): 077570
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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 077570
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Hikma |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Pharmacology for NDA: 077570
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 077570
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 077570 | ANDA | A-S Medication Solutions | 50090-3513 | 50090-3513-0 | 1 BOTTLE, PUMP in 1 CARTON (50090-3513-0) / 16 g in 1 BOTTLE, PUMP |
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 077570 | ANDA | Proficient Rx LP | 63187-021 | 63187-021-16 | 1 BOTTLE, PUMP in 1 CARTON (63187-021-16) / 16 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
Approval Date: | Jan 16, 2008 | TE: | RLD: | No |
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