APPLICATION
ANDA074626
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-23
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUTORPHANOL TARTRATE PRESERVATIVE FREEPrescription
BUTORPHANOL TARTRATE 1MG/ML · INJECTABLE · INJECTION
BUTORPHANOL TARTRATE PRESERVATIVE FREEPrescription
BUTORPHANOL TARTRATE 2MG/ML · INJECTABLE · INJECTION
Approval history
2025-12-22Labeling · Supplement 42 · standardAP
2024-04-04Labeling · Supplement 38 · standardAP
2023-12-19Labeling · Supplement 35 · standardAP
2019-10-11Labeling · Supplement 30 · standardAP
2016-12-16Labeling · Supplement 28 · standardAP
2016-12-16Labeling · Supplement 27 · standardAP
2003-05-08Labeling · Supplement 13AP
2002-10-25Manufacturing (CMC) · Supplement 14AP
2002-09-18Labeling · Supplement 15AP
2001-09-07Manufacturing (CMC) · Supplement 12AP
2001-03-22Manufacturing (CMC) · Supplement 10AP
2001-03-22Manufacturing (CMC) · Supplement 9AP
2001-02-14Manufacturing (CMC) · Supplement 11AP
2000-03-01Manufacturing (CMC) · Supplement 8AP
2000-03-01Manufacturing (CMC) · Supplement 6AP
2000-03-01Manufacturing (CMC) · Supplement 4AP
2000-03-01Labeling · Supplement 5AP
2000-01-07Manufacturing (CMC) · Supplement 2AP
2000-01-07Labeling · Supplement 3AP
1999-10-22Labeling · Supplement 7AP
1998-11-23Manufacturing (CMC) · Supplement 1AP
1997-01-23OriginalAP
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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