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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020169
Company: CONCORDIA

Products on NDA 020169

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020169

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.

Labels for NDA 020169

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

Therapeutic Equivalents for NDA 020169

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

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