APPLICATION
ANDA072123
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-24
LATEST ACTION
2023-02-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DROPERIDOLPrescription
DROPERIDOL 2.5MG/ML · INJECTABLE · INJECTION
Approval history
2023-02-21Labeling · Supplement 22 · standardAP
2002-01-10Labeling · Supplement 12AP
1999-03-25Manufacturing (CMC) · Supplement 8AP
1998-07-02Manufacturing (CMC) · Supplement 7AP
1996-02-28Manufacturing (CMC) · Supplement 4AP
1995-05-26Manufacturing (CMC) · Supplement 2AP
1995-02-17Labeling · Supplement 5AP
1994-10-11Manufacturing (CMC) · Supplement 3AP
1988-10-24OriginalAP
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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