Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076436
Company: DR REDDYS LABS INC
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
07/28/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076436s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2014 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/28/2012 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/27/2011 SUPPL-4 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

08/25/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/11/2011 SUPPL-2 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 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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