Details for New Drug Application (NDA): 208024
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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 208024
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Hikma |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208024
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208024
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 208024 | ANDA | Rugby Laboratories, Inc. | 0536-1373 | 0536-1373-37 | 1 BOTTLE in 1 PACKAGE (0536-1373-37) / 60 SPRAY, METERED in 1 BOTTLE |
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 208024 | ANDA | Rugby Laboratories, Inc. | 0536-1373 | 0536-1373-38 | 1 BOTTLE in 1 PACKAGE (0536-1373-38) / 120 SPRAY, METERED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
Approval Date: | Apr 17, 2019 | TE: | RLD: | No |
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