Details for New Drug Application (NDA): 091553
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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 091553
Tradename: | FLUTICASONE PROPIONATE |
Applicant: | Padagis Israel |
Ingredient: | fluticasone propionate |
Patents: | 0 |
Pharmacology for NDA: 091553
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 091553
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | fluticasone propionate | LOTION;TOPICAL | 091553 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-441 | 45802-441-02 | 60 mL in 1 BOTTLE (45802-441-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jul 30, 2013 | TE: | AB | RLD: | No |
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