APPLICATION
NDA015921
TYPE
NDA
ORIGINAL APPROVAL
1967-04-12
LATEST ACTION
2002-04-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HALDOL · ReferenceDiscontinued
HALOPERIDOL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HALDOL · ReferenceDiscontinued
HALOPERIDOL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HALDOL · ReferenceDiscontinued
HALOPERIDOL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HALDOL · ReferenceDiscontinued
HALOPERIDOL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HALDOL · ReferenceDiscontinued
HALOPERIDOL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HALDOL · ReferenceDiscontinued
HALOPERIDOL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-04-17Labeling · Supplement 76 · priorityAP
2000-05-02Labeling · Supplement 75 · priorityAP
1998-04-23Manufacturing (CMC) · Supplement 71 · priorityAP
1996-05-10Manufacturing (CMC) · Supplement 72 · priorityAP
1995-01-30Manufacturing (CMC) · Supplement 68 · priorityAP
1994-06-29Manufacturing (CMC) · Supplement 67 · priorityAP
1990-04-06Manufacturing (CMC) · Supplement 65 · priorityAP
1988-10-04Manufacturing (CMC) · Supplement 62 · priorityAP
1988-02-17Manufacturing (CMC) · Supplement 61 · priorityAP
1987-10-16Manufacturing (CMC) · Supplement 59 · priorityAP
1986-10-22Manufacturing (CMC) · Supplement 53 · priorityAP
1986-02-06Manufacturing (CMC) · Supplement 48 · priorityAP
1985-04-30Manufacturing (CMC) · Supplement 46 · priorityAP
1985-04-30Manufacturing (CMC) · Supplement 47 · priorityAP
1983-03-18Manufacturing (CMC) · Supplement 38 · priorityAP
1983-03-18Manufacturing (CMC) · Supplement 40 · priorityAP
1983-03-18Manufacturing (CMC) · Supplement 39 · priorityAP
1983-03-11Labeling · Supplement 37 · priorityAP
1983-01-31Labeling · Supplement 36 · priorityAP
1982-09-08Labeling · Supplement 35 · priorityAP
1982-09-03Manufacturing (CMC) · Supplement 34 · priorityAP
1982-06-23Manufacturing (CMC) · Supplement 32 · priorityAP
1982-04-20Manufacturing (CMC) · Supplement 33 · priorityAP
1982-02-02Manufacturing (CMC) · Supplement 26 · priorityAP
1981-10-02Labeling · Supplement 31 · priorityAP
1981-01-23Labeling · Supplement 28 · priorityAP
1981-01-23Labeling · Supplement 29 · priorityAP
1980-03-07Manufacturing (CMC) · Supplement 27 · priorityAP
1980-02-12Labeling · Supplement 24 · priorityAP
1979-07-06Labeling · Supplement 25 · priorityAP
1978-02-13Labeling · Supplement 21 · priorityAP
1977-12-12Manufacturing (CMC) · Supplement 23 · priorityAP
1976-03-26Manufacturing (CMC) · Supplement 20 · priorityAP
1974-12-10Manufacturing (CMC) · Supplement 19 · priorityAP
1974-05-21REMS · Supplement 12 · priorityAP
1967-04-12Type 1 - New Molecular Entity · 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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