Drugs@FDA: FDA Approved Drug Products

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

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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