Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020498
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CASODEX BICALUTAMIDE 50MG TABLET;ORAL Prescription AB Yes Yes
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.

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

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 200274 APOTEX INC
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079045 FRESENIUS KABI USA
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 091011 KENTON
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079185 MYLAN
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
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079089 ZYDUS PHARMS USA INC
CASODEX BICALUTAMIDE 50MG TABLET;ORAL Prescription Yes AB 020498 ANI PHARMS INC

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