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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 020498


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NDA 020498 describes CASODEX, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the CASODEX profile page.

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 ActionAndrogen 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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 4, 1995TE:ABRLD: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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