APPLICATION
ANDA075102
TYPE
ANDA
ORIGINAL APPROVAL
1999-01-04
LATEST ACTION
2025-08-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROPOFOLPrescription
PROPOFOL 10MG/ML · INJECTABLE · INJECTION
Approval history
2025-08-12Labeling · Supplement 46 · standardAP
2017-12-22Labeling · Supplement 38 · standardAP
2017-12-22Labeling · Supplement 40 · standardAP
2016-07-05Labeling · Supplement 35 · standardAP
2015-11-19Labeling · Supplement 32 · standardAP
2012-12-18Manufacturing (CMC) · Supplement 28AP
2009-02-25Labeling · Supplement 14AP
2005-03-10Labeling · Supplement 13AP
2005-02-08Labeling · Supplement 11AP
2002-09-11Manufacturing (CMC) · Supplement 8AP
2002-09-11Labeling · Supplement 9AP
2002-09-11Manufacturing (CMC) · Supplement 7AP
2002-03-06Manufacturing (CMC) · Supplement 6AP
2000-11-16Labeling · Supplement 5AP
2000-02-10Labeling · Supplement 4AP
1999-07-28Manufacturing (CMC) · Supplement 1AP
1999-05-14Labeling · Supplement 3AP
1999-03-23Labeling · Supplement 2AP
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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