APPLICATION
ANDA077867
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-02
LATEST ACTION
2025-10-16
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
SOJOURNPrescription
SEVOFLURANE 100% · LIQUID · INHALATION
Approval history
2025-10-16Labeling · Supplement 30 · standardAP
2020-03-25Labeling · Supplement 18 · standardAP
2015-09-16Labeling · Supplement 11 · standardAP
2015-09-16Labeling · Supplement 9 · standardAP
2015-09-16Labeling · Supplement 12 · standardAP
2012-01-31Labeling · Supplement 8AP
2012-01-20Manufacturing (CMC) · Supplement 7AP
2011-03-16Labeling · Supplement 4AP
2007-05-02OriginalAP
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.