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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019890
Company: BRISTOL MYERS SQUIBB

Products on NDA 019890

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STADOL	BUTORPHANOL TARTRATE	1MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019890

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
03/13/2009	SUPPL-19	Labeling		Label is not available on this site.
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.
03/13/2009	SUPPL-8	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.
03/13/2009	SUPPL-3	Efficacy-New Dosing Regimen		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.

Labels for NDA 019890

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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