Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016885
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYSODREN MITOTANE 500MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/08/1970 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
05/09/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016885s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016885Orig1s027ltr.pdf
03/11/2016 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016885Orig1s026ltr.pdf
11/15/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016885Orig1s025ltr.pdf
02/10/2009 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016885s023ltr.pdf
07/10/2003 SUPPL-22 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16885slr022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016885_S022_Lysodren.pdf
03/29/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/04/1997 SUPPL-20 Labeling

Label is not available on this site.

01/08/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/01/1987 SUPPL-16 Labeling

Label is not available on this site.

04/02/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/30/1986 SUPPL-13 Labeling

Label is not available on this site.

07/21/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/20/1985 SUPPL-11 Labeling

Label is not available on this site.

08/06/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1978 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/24/1985 SUPPL-4 Labeling

Label is not available on this site.

04/24/1978 SUPPL-3 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
05/09/2017 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016885s027lbl.pdf
03/11/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf
11/15/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf
02/10/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf

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