Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204304
Company: ALKEM LABS LTD
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
01/05/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204304Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2017 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

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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