Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090061
Company: HETERO LABS LTD III

Products on ANDA 090061

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090061

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2022	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/11/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/19/2015	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/26/2013	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/22/2013	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/14/2012	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/22/2010	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090061

FINASTERIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	090121	ACCORD HLTHCARE
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	204304	ALKEM LABS LTD
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	078341	AUROBINDO PHARMA
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	076437	DR REDDYS LABS LTD
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	090061	HETERO LABS LTD III
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	090507	SUN PHARM
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	076511	TEVA
FINASTERIDE	FINASTERIDE	5MG	TABLET;ORAL	Prescription	No	AB	078900	ZYDUS PHARMS USA INC
PROSCAR	FINASTERIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	020180	ORGANON