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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076437
Company: DR REDDYS LABS LTD

Products on ANDA 076437

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 076437

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2007	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
09/28/2012	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/29/2012	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
08/03/2011	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/01/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/27/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076437

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

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