Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074069
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZATHIOPRINE AZATHIOPRINE 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
02/16/1996 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
05/25/2017 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/19/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

06/21/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/23/2008 SUPPL-4 Labeling

Label is not available on this site.

02/01/2007 SUPPL-3 Labeling

Label is not available on this site.

06/22/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AZATHIOPRINE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 074069 AMNEAL PHARMS LLC
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 075568 MYLAN
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA
IMURAN AZATHIOPRINE 50MG TABLET;ORAL Prescription Yes AB 016324 SEBELA IRELAND LTD

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