Details for New Drug Application (NDA): 075298
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NDA 075298 describes FLUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Chartwell Rx, Cipla, Norvium Bioscience, and Waylis Therap, and is included in five NDAs. It is available from two suppliers. Additional details are available on the FLUTAMIDE profile page.
The generic ingredient in FLUTAMIDE is flutamide. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flutamide profile page.
The generic ingredient in FLUTAMIDE is flutamide. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flutamide profile page.
Summary for 075298
| Tradename: | FLUTAMIDE |
| Applicant: | Waylis Therap |
| Ingredient: | flutamide |
| Patents: | 0 |
Pharmacology for NDA: 075298
| Mechanism of Action | Androgen Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075298
Suppliers and Packaging for NDA: 075298
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTAMIDE | flutamide | CAPSULE;ORAL | 075298 | ANDA | Waylis Therapeutics LLC | 80725-143 | 80725-143-18 | 1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC |
| FLUTAMIDE | flutamide | CAPSULE;ORAL | 075298 | ANDA | Waylis Therapeutics LLC | 80725-600 | 80725-600-18 | 1 BOTTLE, PLASTIC in 1 BOX (80725-600-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 125MG | ||||
| Approval Date: | Sep 18, 2001 | TE: | RLD: | No | |||||
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