APPLICATION
NDA016796
TYPE
NDA
ORIGINAL APPROVAL
1970-06-11
LATEST ACTION
2001-11-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
INAPSINE · ReferenceDiscontinued
DROPERIDOL 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-12-14Manufacturing (CMC) · Supplement 37 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 36 · standardAP
2000-02-18Labeling · Supplement 35 · standardAP
1998-09-29Manufacturing (CMC) · Supplement 34 · standardAP
1995-03-15Manufacturing (CMC) · Supplement 32 · standardAP
1995-02-22Manufacturing (CMC) · Supplement 33 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 29 · standardAP
1994-03-02Labeling · Supplement 30 · standardAP
1992-10-28Manufacturing (CMC) · Supplement 28 · standardAP
1990-10-05Manufacturing (CMC) · Supplement 27 · standardAP
1988-12-06Manufacturing (CMC) · Supplement 25 · standardAP
1987-12-31Labeling · Supplement 20AP
1987-12-31Manufacturing (CMC) · Supplement 19 · standardAP
1987-07-17Manufacturing (CMC) · Supplement 26 · standardAP
1987-04-02Labeling · Supplement 22AP
1986-12-15Labeling · Supplement 24AP
1986-12-15Manufacturing (CMC) · Supplement 23 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 21 · standardAP
1982-08-13Manufacturing (CMC) · Supplement 15 · standardAP
1982-07-28Manufacturing (CMC) · Supplement 12 · standardAP
1982-07-28Labeling · Supplement 13AP
1982-01-20Manufacturing (CMC) · Supplement 14 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 10 · standardAP
1976-11-08Manufacturing (CMC) · Supplement 8 · standardAP
1974-08-29Labeling · Supplement 5AP
1970-06-11Type 3 - New Dosage Form · Original · standardAP
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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