APPLICATION
NDA017857
TYPE
NDA
ORIGINAL APPROVAL
1978-08-22
LATEST ACTION
2001-11-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
STADOL · ReferenceDiscontinued
BUTORPHANOL TARTRATE 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
STADOL PRESERVATIVE FREE · ReferenceDiscontinued
BUTORPHANOL TARTRATE 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
STADOL PRESERVATIVE FREE · ReferenceDiscontinued
BUTORPHANOL TARTRATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-11-05Manufacturing (CMC) · Supplement 58 · priorityAP
1999-05-25Labeling · Supplement 54 · priorityAP
1998-03-13Labeling · Supplement 53 · priorityAP
1998-03-13Labeling · Supplement 51 · priorityAP
1993-04-16Labeling · Supplement 50 · priorityAP
1993-04-16Labeling · Supplement 49 · priorityAP
1992-05-01Labeling · Supplement 48 · priorityAP
1990-09-19Manufacturing (CMC) · Supplement 47 · priorityAP
1988-12-12Manufacturing (CMC) · Supplement 44 · priorityAP
1987-08-04Manufacturing (CMC) · Supplement 12 · priorityAP
1987-08-04Labeling · Supplement 43 · priorityAP
1987-08-04Manufacturing (CMC) · Supplement 13 · priorityAP
1987-03-05Efficacy · Supplement 39 · priorityAP
1987-01-14Manufacturing (CMC) · Supplement 42 · priorityAP
1986-10-20Manufacturing (CMC) · Supplement 41 · priorityAP
1985-07-22Manufacturing (CMC) · Supplement 36 · priorityAP
1985-01-10Manufacturing (CMC) · Supplement 37 · priorityAP
1984-10-24Manufacturing (CMC) · Supplement 29 · priorityAP
1984-10-19Labeling · Supplement 35 · priorityAP
1984-06-07Labeling · Supplement 34 · priorityAP
1984-06-07Labeling · Supplement 33 · priorityAP
1984-05-09Labeling · Supplement 32 · priorityAP
1984-05-07Manufacturing (CMC) · Supplement 27 · priorityAP
1984-04-16Labeling · Supplement 31 · priorityAP
1984-04-04Labeling · Supplement 30 · priorityAP
1984-01-17Labeling · Supplement 26 · priorityAP
1983-09-07Labeling · Supplement 25 · priorityAP
1983-04-20Manufacturing (CMC) · Supplement 24 · priorityAP
1983-04-20Manufacturing (CMC) · Supplement 23 · priorityAP
1982-09-07Manufacturing (CMC) · Supplement 10 · priorityAP
1982-02-26Efficacy · Supplement 22 · priorityAP
1981-09-02Manufacturing (CMC) · Supplement 16 · priorityAP
1981-05-14Labeling · Supplement 20 · priorityAP
1981-05-14Labeling · Supplement 19 · priorityAP
1980-06-03Manufacturing (CMC) · Supplement 15 · priorityAP
1979-11-20Labeling · Supplement 9 · priorityAP
1979-11-20Labeling · Supplement 7 · priorityAP
1979-11-20Labeling · Supplement 5 · priorityAP
1979-11-20Labeling · Supplement 6 · priorityAP
1979-05-15Manufacturing (CMC) · Supplement 11 · priorityAP
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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