Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077621
Company: ZYDUS PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription AB No No
AZATHIOPRINE AZATHIOPRINE 25MG TABLET;ORAL Prescription AB No No
AZATHIOPRINE AZATHIOPRINE 75MG TABLET;ORAL Prescription AB No No
AZATHIOPRINE AZATHIOPRINE 100MG 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
03/15/2007 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
07/20/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/20/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/17/2009 SUPPL-4 Labeling

Label is not available on this site.

09/05/2008 SUPPL-2 Labeling

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

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

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