Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078341
Company: AUROBINDO PHARMA

Products on ANDA 078341

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 078341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2007	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
05/18/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
05/18/2022	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/18/2022	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
05/18/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
12/23/2015	SUPPL-15	Labeling-Container/Carton Labels		Label is not available on this site.
12/14/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/26/2013	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/23/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/10/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/19/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078341

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