Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020169
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NILANDRON NILUTAMIDE 50MG TABLET;ORAL Discontinued None No No
NILANDRON NILUTAMIDE 150MG 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
09/19/1996 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/pre96/020169Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020169s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020169Orig1s008ltr.pdf
09/28/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/13/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/26/2004 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20169s003ltr.pdf
09/29/2000 SUPPL-2 Labeling

Label is not available on this site.

04/30/1999 SUPPL-1 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
05/17/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020169s008lbl.pdf

NILANDRON

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NILANDRON NILUTAMIDE 150MG TABLET;ORAL Prescription Yes AB 020169 CONCORDIA
NILUTAMIDE NILUTAMIDE 150MG TABLET;ORAL Prescription No AB 207631 ANI PHARMS INC

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