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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090060
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FINASTERIDE FINASTERIDE 1MG 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
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
05/05/2022 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/22/2016 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/14/2014 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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 077335 CIPLA
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
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