Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207631
Company: ANI PHARMS

Products on ANDA 207631

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NILUTAMIDE	NILUTAMIDE	150MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207631

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207631Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207631Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207631Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/04/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 207631

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207631Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207631

NILUTAMIDE

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