APPLICATION
ANDA072335
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-23
LATEST ACTION
1999-03-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DROPERIDOLDiscontinued
DROPERIDOL 2.5MG/ML · INJECTABLE · INJECTION
Approval history
1999-03-25Manufacturing (CMC) · Supplement 9AP
1998-10-13Manufacturing (CMC) · Supplement 8AP
1998-07-15Manufacturing (CMC) · Supplement 7AP
1996-02-28Manufacturing (CMC) · Supplement 5AP
1995-03-08Manufacturing (CMC) · Supplement 3AP
1995-02-17Labeling · Supplement 6AP
1994-10-11Manufacturing (CMC) · Supplement 4AP
1992-02-13Labeling · Supplement 1AP
1988-10-23OriginalAP
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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