DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077704
NDA 077704 describes FLUNISOLIDE, which is a drug marketed by Apotex Inc, Bausch And Lomb, and Hi Tech Pharma Co, and is included in three NDAs. It is available from four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the flunisolide profile page.
Summary for 077704
| Tradename: | FLUNISOLIDE |
| Applicant: | Hi Tech Pharma Co |
| Ingredient: | flunisolide |
| Patents: | 0 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077704
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 077704
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 077704 | ANDA | Rising Pharmaceuticals, Inc | 64980-510 | E | 64980-510-25 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.025MG/SPRAY | ||||
| Approval Date: | Aug 3, 2006 | TE: | AB | RLD: | No | ||||
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