Details for New Drug Application (NDA): 020498
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The generic ingredient in CASODEX 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 020498
Tradename: | CASODEX |
Applicant: | Ani Pharms |
Ingredient: | bicalutamide |
Patents: | 0 |
Pharmacology for NDA: 020498
Mechanism of Action | Androgen Receptor Antagonists |
Suppliers and Packaging for NDA: 020498
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CASODEX | bicalutamide | TABLET;ORAL | 020498 | NDA | ANI Pharmaceuticals, Inc. | 62559-680 | 62559-680-30 | 30 TABLET in 1 BOTTLE (62559-680-30) |
CASODEX | bicalutamide | TABLET;ORAL | 020498 | NDA | ANI Pharmaceuticals, Inc. | 62559-890 | 62559-890-30 | 30 TABLET in 1 BOTTLE (62559-890-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Oct 4, 1995 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020498
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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