APPLICATION
ANDA078247
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-29
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUTORPHANOL TARTRATEDiscontinued
BUTORPHANOL TARTRATE 2MG/ML · INJECTABLE · INJECTION
Approval history
2025-12-22Labeling · Supplement 9 · standardAP
2024-01-16Labeling · Supplement 6 · standardAP
2024-01-16Labeling · Supplement 7 · standardAP
2020-09-15Labeling · Supplement 5 · standardAP
2016-12-16Labeling · Supplement 2 · standardAP
2016-12-16Labeling · Supplement 3 · standardAP
2009-04-29OriginalAP
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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