Last Updated: September 24, 2026

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 two suppliers. Additional details are available on the CASODEX profile page.

The generic ingredient in CASODEX is bicalutamide. There is one drug master file entry 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	Golden State Medical Supply, Inc.	51407-010	51407-010-30	30 TABLET in 1 BOTTLE (51407-010-30)
CASODEX	bicalutamide	TABLET;ORAL	020498	NDA	ANI Pharmaceuticals, Inc.	62559-680	62559-680-30	30 TABLET in 1 BOTTLE (62559-680-30)

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	1,712,251	⤷ Start Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,712,251	⤷ Start Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,389,613	⤷ Start Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	4,472,382	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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