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FDA ANDA · ANDA071015

HALOPERIDOL

Sponsor: TEVA

APPLICATION
ANDA071015
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-25
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

HALOPERIDOLDiscontinued
HALOPERIDOL LACTATE EQ 2MG BASE/ML · CONCENTRATE · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 17AP
2000-07-07Manufacturing (CMC) · Supplement 16AP
1997-07-08Manufacturing (CMC) · Supplement 15AP
1994-11-02Manufacturing (CMC) · Supplement 13AP
1994-11-02Manufacturing (CMC) · Supplement 14AP
1994-11-02Manufacturing (CMC) · Supplement 12AP
1993-10-21Manufacturing (CMC) · Supplement 11AP
1993-10-21Manufacturing (CMC) · Supplement 8AP
1993-10-21Manufacturing (CMC) · Supplement 6AP
1993-10-21Manufacturing (CMC) · Supplement 10AP
1993-10-21Manufacturing (CMC) · Supplement 9AP
1993-10-21Manufacturing (CMC) · Supplement 7AP
1993-09-08Manufacturing (CMC) · Supplement 5AP
1989-08-29Manufacturing (CMC) · Supplement 3AP
1989-06-12Labeling · Supplement 4AP
1989-01-27Manufacturing (CMC) · Supplement 1AP
1988-09-22Labeling · Supplement 2AP
1987-08-25OriginalAP
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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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