Details for New Drug Application (NDA): 207802
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NDA 207802 describes FLUNISOLIDE, which is a drug marketed by Apotex, Bausch, Riconpharma Llc, and Rising, and is included in four NDAs. It is available from two suppliers. Additional details are available on the FLUNISOLIDE profile page.
The generic ingredient in FLUNISOLIDE is flunisolide. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flunisolide profile page.
The generic ingredient in FLUNISOLIDE is flunisolide. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flunisolide profile page.
Summary for 207802
| Tradename: | FLUNISOLIDE |
| Applicant: | Riconpharma Llc |
| Ingredient: | flunisolide |
| Patents: | 0 |
Pharmacology for NDA: 207802
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207802
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 207802 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-317 | 50742-317-25 | 1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.025MG/SPRAY | ||||
| Approval Date: | Jun 16, 2022 | TE: | AB | RLD: | No | ||||
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