Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016324
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMURAN AZATHIOPRINE 50MG TABLET;ORAL Prescription AB Yes Yes
IMURAN AZATHIOPRINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
03/20/1968 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2014 SUPPL-37 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391Orig1s016ltr.pdf
05/21/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/24/2011 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf
05/24/2011 SUPPL-34 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf
07/09/2008 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016324s031, 017391s014LTR.pdf
07/26/2005 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016324s030,017391s013ltr.pdf
12/19/2002 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf
10/26/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/09/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/18/1988 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/1988 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1994 SUPPL-11 Labeling

Label is not available on this site.

04/13/1981 SUPPL-10 Efficacy

Label is not available on this site.

03/21/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2014 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf
05/24/2011 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf
05/24/2011 SUPPL-34 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf
07/09/2008 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf
07/26/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf

IMURAN

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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