APPLICATION
ANDA075392
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-19
LATEST ACTION
2002-10-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROPOFOLDiscontinued
PROPOFOL 10MG/ML · INJECTABLE · INJECTION
Approval history
2002-10-17Labeling · Supplement 4AP
2002-03-06Manufacturing (CMC) · Supplement 3AP
2001-03-20Manufacturing (CMC) · Supplement 1AP
2000-11-16Labeling · 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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