Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040594
Company: MYLAN
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
07/01/2005 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
01/29/2021 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/10/2018 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/14/2013 SUPPL-6 Labeling-Container/Carton Labels

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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