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FDA ANDA · ANDA071237

HALOPERIDOL

Sponsor: VINTAGE

APPLICATION
ANDA071237
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-20
LATEST ACTION
2015-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HALOPERIDOLDiscontinued
HALOPERIDOL 10MG · TABLET · ORAL

Approval history

2015-03-18Labeling · Supplement 15AP
1993-10-27Labeling · Supplement 14AP
1989-03-09Labeling · Supplement 13AP
1987-11-20Manufacturing (CMC) · Supplement 5AP
1987-09-15Manufacturing (CMC) · Supplement 4AP
1987-08-24Manufacturing (CMC) · Supplement 2AP
1987-08-24Manufacturing (CMC) · Supplement 3AP
1987-07-20OriginalAP
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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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