Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019890
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STADOL BUTORPHANOL TARTRATE 1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED;NASAL Discontinued None No No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
12/12/1991 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2002 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19890s17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19890s17ltr.pdf
01/05/2001 SUPPL-15 Labeling

Label is not available on this site.

04/16/1999 SUPPL-14 Labeling

Label is not available on this site.

06/16/1998 SUPPL-13 Labeling

Label is not available on this site.

03/13/1998 SUPPL-12 Labeling

Label is not available on this site.

04/18/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-10 Labeling

Label is not available on this site.

03/13/1998 SUPPL-9 Labeling

Label is not available on this site.

07/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-5 Labeling

Label is not available on this site.

03/13/1998 SUPPL-4 Labeling

Label is not available on this site.

04/16/1993 SUPPL-2 Labeling

Label is not available on this site.

04/02/1993 SUPPL-1 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
01/14/2002 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19890s17lbl.pdf

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