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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020498
Company: ANI PHARMS

Products on NDA 020498

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CASODEX	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020498

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/04/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020498Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2017	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020498Orig1s028ltr.pdf
03/17/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020498Orig1s027ltr.pdf
02/27/2015	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020498s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020498Orig1s025ltr.pdf
09/12/2013	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/15/2010	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020498s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020498s022ltr.pdf
03/13/2009	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf
03/13/2009	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf
03/10/2006	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020498s018ltr.pdf
05/11/2005	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020498s016ltr.pdf
09/23/2002	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/25/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/2001	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/28/2001	SUPPL-8	Labeling		Label is not available on this site.
12/11/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/04/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/12/1997	SUPPL-4	Efficacy-New Indication		Label is not available on this site.
11/12/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020498

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2017	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf
03/17/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s027lbl.pdf
02/27/2015	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020498s025lbl.pdf
09/15/2010	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020498s022lbl.pdf
03/13/2009	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf
03/13/2009	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf
03/10/2006	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf
05/11/2005	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf

Therapeutic Equivalents for NDA 020498

CASODEX

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	078917	ACCORD HLTHCARE
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	079089	ADAPTIS
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	200274	APOTEX
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	091011	CHARTWELL RX
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	078575	SANDOZ
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	079110	SUN PHARM
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	078634	WATSON LABS TEVA
CASODEX	BICALUTAMIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	020498	ANI PHARMS

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