APPLICATION
ANDA075170
TYPE
ANDA
ORIGINAL APPROVAL
1998-09-28
LATEST ACTION
2002-12-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUTORPHANOL TARTRATE PRESERVATIVE FREEDiscontinued
BUTORPHANOL TARTRATE 1MG/ML · INJECTABLE · INJECTION
BUTORPHANOL TARTRATE PRESERVATIVE FREEDiscontinued
BUTORPHANOL TARTRATE 2MG/ML · INJECTABLE · INJECTION
Approval history
2002-12-20Manufacturing (CMC) · Supplement 9AP
2002-05-03Manufacturing (CMC) · Supplement 8AP
2002-05-03Manufacturing (CMC) · Supplement 7AP
2001-06-28Manufacturing (CMC) · Supplement 6AP
2001-06-13Manufacturing (CMC) · Supplement 4AP
2000-08-18Manufacturing (CMC) · Supplement 2AP
1999-12-01Labeling · Supplement 3AP
1999-07-22Manufacturing (CMC) · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.