Details for New Drug Application (NDA): 218742
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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 218742
| Tradename: | FLUTICASONE PROPIONATE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | fluticasone propionate |
| Patents: | 0 |
Pharmacology for NDA: 218742
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 218742
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 218742 | ANDA | GLENMARK THERAPEUTICS INC., USA | 72657-159 | 72657-159-12 | 1 BOTTLE in 1 CARTON (72657-159-12) / 120 SPRAY, METERED in 1 BOTTLE |
| FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 218742 | ANDA | GLENMARK THERAPEUTICS INC., USA | 72657-159 | 72657-159-14 | 1 BOTTLE in 1 CARTON (72657-159-14) / 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: | Mar 16, 2026 | TE: | RLD: | No | |||||
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