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Details for New Drug Application (NDA): 079089
NDA 079089 describes BICALUTAMIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Fresenius Kabi Oncol, Kudco Ireland, Mylan, Roxane, Sandoz, Santos Biotech, Sun Pharma Global, Synthon Pharms, Teva, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from seventeen suppliers. Additional details are available on the BICALUTAMIDE profile page.
The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 079089
| Tradename: | BICALUTAMIDE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | bicalutamide |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Suppressant (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079089
| Mechanism of Action | Androgen Receptor Antagonists |
Suppliers and Packaging for NDA: 079089
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079089 | ANDA | Cadila Healthcare Limited | 65841-613 | N | 65841-613-10 |
| BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079089 | ANDA | Cadila Healthcare Limited | 65841-613 | N | 65841-613-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 6, 2009 | TE: | AB | RLD: | No | ||||
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