APPLICATION
ANDA071206
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-17
LATEST ACTION
2017-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL 0.5MG · TABLET · ORAL
Approval history
2017-02-23Labeling · Supplement 35 · standardAP
2010-12-06Labeling · Supplement 30AP
2009-07-16Labeling · Supplement 28AP
2008-09-08Labeling · Supplement 27AP
2008-05-29Labeling · Supplement 24AP
2008-04-02Labeling · Supplement 23AP
2002-09-05Labeling · Supplement 21AP
2001-10-16Labeling · Supplement 18AP
1998-09-21Labeling · Supplement 13AP
1990-04-20Labeling · Supplement 37AP
1990-04-20Labeling · Supplement 10AP
1989-06-01Labeling · Supplement 8AP
1988-09-09Labeling · Supplement 7AP
1986-11-17OriginalAP
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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