APPLICATION
ANDA072759
TYPE
ANDA
ORIGINAL APPROVAL
1990-07-31
LATEST ACTION
2018-07-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PANCURONIUM BROMIDEPrescription
PANCURONIUM BROMIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2018-07-26Labeling · Supplement 26 · standardAP
2012-05-10Labeling · Supplement 19AP
2010-11-22Labeling · Supplement 13AP
2009-04-24Labeling · Supplement 8AP
2004-03-29Labeling · Supplement 4AP
1994-04-18Manufacturing (CMC) · Supplement 2AP
1992-08-14Labeling · Supplement 1AP
1990-07-31OriginalAP
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.