Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040461
Company: DR REDDYS LABS SA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MERCAPTOPURINE MERCAPTOPURINE 50MG 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
02/11/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40461ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/18/2005 SUPPL-2 Labeling

Label is not available on this site.

01/28/2005 SUPPL-1 Labeling

Label is not available on this site.

MERCAPTOPURINE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MERCAPTOPURINE MERCAPTOPURINE 50MG TABLET;ORAL Prescription No AB 040461 DR REDDYS LABS SA
MERCAPTOPURINE MERCAPTOPURINE 50MG TABLET;ORAL Prescription No AB 040528 HIKMA
MERCAPTOPURINE MERCAPTOPURINE 50MG TABLET;ORAL Prescription No AB 040594 MYLAN
PURINETHOL MERCAPTOPURINE 50MG TABLET;ORAL Prescription Yes AB 009053 STASON PHARMS

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