APPLICATION
ANDA077908
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-17
LATEST ACTION
2025-09-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROPOFOLPrescription
PROPOFOL 10MG/ML · INJECTABLE · INJECTION
Approval history
2025-09-19Labeling · Supplement 36 · standardAP
2016-05-29Labeling · Supplement 26 · standardAP
2014-11-07Manufacturing (CMC) · Supplement 23AP
2008-08-12Labeling · Supplement 8AP
2008-01-14Labeling · Supplement 7AP
2007-10-30Labeling · Supplement 3AP
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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