APPLICATION
ANDA075045
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-12
LATEST ACTION
2025-12-22
ROUTE
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 18 · standardAP
2024-01-10Labeling · Supplement 16 · standardAP
2024-01-10Labeling · Supplement 17 · standardAP
2019-10-11Labeling · Supplement 15 · standardAP
2001-10-30Labeling · Supplement 3AP
2001-04-03Manufacturing (CMC) · Supplement 2AP
1999-10-15Labeling · Supplement 1AP
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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