APPLICATION
ANDA071981
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-29
LATEST ACTION
2002-01-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DROPERIDOLDiscontinued
DROPERIDOL 2.5MG/ML · INJECTABLE · INJECTION
Approval history
2002-01-24Labeling · Supplement 9AP
1996-10-03Manufacturing (CMC) · Supplement 7AP
1996-01-30Labeling · Supplement 5AP
1994-06-28Manufacturing (CMC) · Supplement 4AP
1994-01-11Manufacturing (CMC) · Supplement 3AP
1989-07-20Labeling · Supplement 2AP
1989-06-12Manufacturing (CMC) · Supplement 1AP
1988-02-29OriginalAP
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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