Details for New Drug Application (NDA): 207957
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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 207957
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Hikma |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Pharmacology for NDA: 207957
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207957
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 207957 | ANDA | L. Perrigo Company | 0113-0028 | 0113-0028-08 | 1 BOTTLE in 1 CARTON (0113-0028-08) / 72 SPRAY, METERED in 1 BOTTLE |
FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 207957 | ANDA | L. Perrigo Company | 0113-0028 | 0113-0028-09 | 1 BOTTLE in 1 CARTON (0113-0028-09) / 144 SPRAY, METERED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
Approval Date: | May 26, 2016 | TE: | RLD: | No |
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