Details for New Drug Application (NDA): 078917
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NDA 078917 describes BICALUTAMIDE, which is a drug marketed by Accord Hlthcare, Adaptis, Apotex, Chartwell Rx, Fresenius Kabi Usa, Kudco Ireland, Rising, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, and Watson Labs Teva, and is included in thirteen NDAs. It is available from seven 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 078917
| Tradename: | BICALUTAMIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | bicalutamide |
| Patents: | 0 |
Pharmacology for NDA: 078917
| Mechanism of Action | Androgen Receptor Antagonists |
Suppliers and Packaging for NDA: 078917
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917 | ANDA | Major Pharmaceuticals | 0904-6019 | 0904-6019-46 | 30 TABLET in 1 BOTTLE (0904-6019-46) |
| BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917 | ANDA | Northstar RxLLC | 16714-816 | 16714-816-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-816-01) |
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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