Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090061
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription AB No No
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
03/19/2015 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/06/2015 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

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.

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 077914 ACTAVIS TOTOWA TEVA
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 MERCK

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