Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207750
Company: ALKEM LABS LTD

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
01/06/2017 ORIG-1 Approval STANDARD

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 078371 ACTAVIS TOTOWA
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
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 076905 TEVA
PROPECIA FINASTERIDE 1MG TABLET;ORAL Prescription Yes AB 020788 MERCK

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