Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050443
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLENOXANE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
BLENOXANE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
07/31/1973 ORIG-1 Approval Type 1 - New Molecular Entity UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050443s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050443s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050443Orig1s036.pdf
03/21/2003 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50443slr035_blenoxane_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50443slr035ltr.pdf
03/20/2002 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/03/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/12/2000 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/03/2000 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/20/1999 SUPPL-29 Labeling

Label is not available on this site.

08/25/1999 SUPPL-28 Labeling

Label is not available on this site.

06/30/2004 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50443slr027ltr.pdf
09/30/1996 SUPPL-26 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050443s026_blenoxane.pdf
02/20/1996 SUPPL-25 Efficacy-New Indication

Label is not available on this site.

09/07/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/23/1993 SUPPL-23 Labeling

Label is not available on this site.

01/21/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/30/1991 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1983 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1983 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/26/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1983 SUPPL-11 Labeling

Label is not available on this site.

12/13/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1976 SUPPL-9 Labeling

Label is not available on this site.

03/15/1976 SUPPL-8 Labeling

Label is not available on this site.

03/31/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1976 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/08/1975 SUPPL-4 Labeling

Label is not available on this site.

03/05/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1974 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/10/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050443s036lbl.pdf
03/21/2003 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50443slr035_blenoxane_lbl.pdf

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