Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203687
Company: AUROBINDO PHARMA LTD

Products on ANDA 203687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203687

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2013	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
01/23/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/23/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/25/2016	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/14/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203687

FINASTERIDE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	No	AB	091643	ACCORD HLTHCARE
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	No	AB	207750	ALKEM LABS LTD
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	No	AB	203687	AUROBINDO PHARMA LTD
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	No	AB	076436	DR REDDYS LABS INC
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	No	AB	090060	HETERO LABS LTD III
FINASTERIDE	FINASTERIDE	1MG	TABLET;ORAL	Prescription	No	AB	090508	SUN PHARM
PROPECIA	FINASTERIDE	1MG	TABLET;ORAL	Prescription	Yes	AB	020788	ORGANON