APPLICATION
NDA015922
TYPE
NDA
ORIGINAL APPROVAL
1967-04-12
LATEST ACTION
2002-04-17
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
HALDOL · ReferenceDiscontinued
HALOPERIDOL LACTATE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL
Approval history
2002-04-17Labeling · Supplement 66 · priorityAP
2000-05-02Labeling · Supplement 65 · priorityAP
1998-04-23Manufacturing (CMC) · Supplement 61 · priorityAP
1996-05-10Manufacturing (CMC) · Supplement 62 · priorityAP
1995-01-30Manufacturing (CMC) · Supplement 59 · priorityAP
1994-06-29Manufacturing (CMC) · Supplement 58 · priorityAP
1989-07-07Manufacturing (CMC) · Supplement 56 · priorityAP
1988-07-14Manufacturing (CMC) · Supplement 52 · priorityAP
1988-04-13Manufacturing (CMC) · Supplement 53 · priorityAP
1987-01-08Manufacturing (CMC) · Supplement 40 · priorityAP
1986-10-22Manufacturing (CMC) · Supplement 43 · priorityAP
1986-10-22Manufacturing (CMC) · Supplement 42 · priorityAP
1986-01-14Manufacturing (CMC) · Supplement 37 · priorityAP
1986-01-14Manufacturing (CMC) · Supplement 35 · priorityAP
1986-01-14Manufacturing (CMC) · Supplement 33 · priorityAP
1986-01-14Manufacturing (CMC) · Supplement 36 · priorityAP
1983-03-11Labeling · Supplement 28 · priorityAP
1983-01-31Labeling · Supplement 27 · priorityAP
1982-09-08Labeling · Supplement 26 · priorityAP
1982-06-23Manufacturing (CMC) · Supplement 24 · priorityAP
1982-04-20Manufacturing (CMC) · Supplement 25 · priorityAP
1981-10-02Labeling · Supplement 23 · priorityAP
1981-01-23Labeling · Supplement 20 · priorityAP
1981-01-23Labeling · Supplement 21 · priorityAP
1980-07-28Manufacturing (CMC) · Supplement 18 · priorityAP
1980-05-19Manufacturing (CMC) · Supplement 19 · priorityAP
1980-02-12Labeling · Supplement 14 · priorityAP
1980-01-15Manufacturing (CMC) · Supplement 16 · priorityAP
1979-07-06Labeling · Supplement 17 · priorityAP
1979-07-06Labeling · Supplement 15 · priorityAP
1979-04-12Manufacturing (CMC) · Supplement 13 · priorityAP
1978-02-13Labeling · Supplement 12 · priorityAP
1967-04-12Type 3 - New Dosage Form · Original · priorityAP
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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