Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090508
Company: SUN PHARM

Products on ANDA 090508

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 090508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2013	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
11/03/2014	SUPPL-3	Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090508

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