DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077704
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 three 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. Three 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. Three 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 |
| 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 | 64980-510-25 | 1 BOTTLE, SPRAY in 1 CARTON (64980-510-25) > 25 mL in 1 BOTTLE, SPRAY |
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 | ||||
Complete Access Available with Subscription
