APPLICATION
NDA017111
TYPE
NDA
ORIGINAL APPROVAL
1974-01-18
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued
Products
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOBAN · ReferenceDiscontinued
MOLINDONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
1998-08-21Manufacturing (CMC) · Supplement 53 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 54 · standardAP
1996-04-25Manufacturing (CMC) · Supplement 51 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 50 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 49 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 48 · standardAP
1994-08-12Manufacturing (CMC) · Supplement 47 · standardAP
1988-08-08Manufacturing (CMC) · Supplement 46 · standardAP
1988-06-28Manufacturing (CMC) · Supplement 44 · standardAP
1988-06-28Labeling · Supplement 45AP
1987-09-23Manufacturing (CMC) · Supplement 43 · standardAP
1986-06-11Manufacturing (CMC) · Supplement 39 · standardAP
1985-06-26Manufacturing (CMC) · Supplement 36 · standardAP
1982-11-19Labeling · Supplement 33AP
1981-03-24Labeling · Supplement 30AP
1981-01-06Manufacturing (CMC) · Supplement 29 · standardAP
1981-01-05Manufacturing (CMC) · Supplement 21 · standardAP
1979-12-20Manufacturing (CMC) · Supplement 23 · standardAP
1979-09-27Manufacturing (CMC) · Supplement 27 · standardAP
1979-08-16Labeling · Supplement 28AP
1979-05-10Labeling · Supplement 26AP
1977-06-07Manufacturing (CMC) · Supplement 17 · standardAP
1977-05-27Manufacturing (CMC) · Supplement 11 · standardAP
1977-03-14Manufacturing (CMC) · Supplement 10 · standardAP
1977-02-07Manufacturing (CMC) · Supplement 14 · standardAP
1977-02-07Manufacturing (CMC) · Supplement 12 · standardAP
1976-09-20Labeling · Supplement 7AP
1976-08-26Manufacturing (CMC) · Supplement 8 · standardAP
1974-09-23Manufacturing (CMC) · Supplement 4 · standardAP
1974-01-18Type 1 - New Molecular Entity · Original · standardAP
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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