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FDA NDA · NDA019890

STADOL

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA019890
TYPE
NDA
ORIGINAL APPROVAL
1991-12-12
LATEST ACTION
2009-03-13
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

STADOL · ReferenceDiscontinued
BUTORPHANOL TARTRATE 1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2009-03-13Labeling · Supplement 8 · standardAP
2009-03-13Labeling · Supplement 19 · standardAP
2009-03-13Efficacy · Supplement 3 · standardAP
2002-01-14Labeling · Supplement 17 · standard — Letter ↗AP
2001-01-05Labeling · Supplement 15 · standardAP
1999-04-16Labeling · Supplement 14 · standardAP
1998-06-16Labeling · Supplement 13 · standardAP
1998-03-13Labeling · Supplement 12 · standardAP
1998-03-13Labeling · Supplement 4 · standardAP
1998-03-13Labeling · Supplement 10 · standardAP
1998-03-13Labeling · Supplement 9 · standardAP
1998-03-13Labeling · Supplement 5 · standardAP
1997-04-18Manufacturing (CMC) · Supplement 11 · standardAP
1996-07-25Manufacturing (CMC) · Supplement 7 · standardAP
1993-04-16Labeling · Supplement 2 · standardAP
1993-04-02Manufacturing (CMC) · Supplement 1 · standardAP
1991-12-12Type 3 - New Dosage Form · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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