Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017391
Company: CASPER PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMURAN AZATHIOPRINE SODIUM EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
07/19/1974 ORIG-1 Approval Type 3 - New Dosage Form 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
12/20/2018 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017391s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017391Orig1s017Ltr.pdf
02/06/2014 SUPPL-16 Labeling-Package Insert 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
05/24/2011 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017391s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf
07/09/2008 SUPPL-14 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-13 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
09/26/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/19/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf
11/09/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/02/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/23/1992 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1994 SUPPL-3 Labeling

Label is not available on this site.

04/23/1982 SUPPL-2 Labeling

Label is not available on this site.

09/20/1978 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017391s017lbl.pdf
02/06/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf
05/24/2011 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017391s015lbl.pdf
07/09/2008 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf
07/26/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf

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