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Details for New Drug Application (NDA): 079089
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The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Ten 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 |
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 | 65841-613-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-613-01) |
BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079089 | ANDA | Cadila Healthcare Limited | 65841-613 | 65841-613-05 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-613-05) |
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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