APPLICATION
NDA016774
TYPE
NDA
ORIGINAL APPROVAL
1970-02-27
LATEST ACTION
2001-07-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SERENTILDiscontinued
MESORIDAZINE BESYLATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERENTILDiscontinued
MESORIDAZINE BESYLATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERENTILDiscontinued
MESORIDAZINE BESYLATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SERENTILDiscontinued
MESORIDAZINE BESYLATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-07-06Manufacturing (CMC) · Supplement 74 · standardAP
2001-03-28Manufacturing (CMC) · Supplement 75 · standardAP
2000-09-06Labeling · Supplement 72 · standardAP
1997-03-14Manufacturing (CMC) · Supplement 71 · standardAP
1995-11-22Manufacturing (CMC) · Supplement 70 · standardAP
1995-10-17Manufacturing (CMC) · Supplement 69 · standardAP
1994-08-01Manufacturing (CMC) · Supplement 66 · standardAP
1994-07-01Manufacturing (CMC) · Supplement 61 · standardAP
1990-11-30Manufacturing (CMC) · Supplement 62 · standardAP
1990-03-14Manufacturing (CMC) · Supplement 56 · standardAP
1989-11-03Manufacturing (CMC) · Supplement 59 · standardAP
1989-08-15Manufacturing (CMC) · Supplement 58 · standardAP
1989-05-10Manufacturing (CMC) · Supplement 57 · standardAP
1987-08-20Manufacturing (CMC) · Supplement 54 · standardAP
1987-05-26Manufacturing (CMC) · Supplement 53 · standardAP
1987-04-23Manufacturing (CMC) · Supplement 52 · standardAP
1986-10-17Manufacturing (CMC) · Supplement 45 · standardAP
1986-03-24Manufacturing (CMC) · Supplement 50 · standardAP
1985-10-23Manufacturing (CMC) · Supplement 49 · standardAP
1985-05-08Manufacturing (CMC) · Supplement 47 · standardAP
1984-03-14Manufacturing (CMC) · Supplement 46 · standardAP
1983-01-19Manufacturing (CMC) · Supplement 42 · standardAP
1982-11-05Labeling · Supplement 43 · standardAP
1981-06-22Manufacturing (CMC) · Supplement 41 · standardAP
1981-03-24Manufacturing (CMC) · Supplement 39 · standardAP
1980-12-10Labeling · Supplement 38 · standardAP
1980-03-07Manufacturing (CMC) · Supplement 37 · standardAP
1980-01-16Manufacturing (CMC) · Supplement 36 · standardAP
1979-08-30Manufacturing (CMC) · Supplement 34 · standardAP
1979-04-04Manufacturing (CMC) · Supplement 35 · standardAP
1978-12-08Manufacturing (CMC) · Supplement 32 · standardAP
1978-06-12Manufacturing (CMC) · Supplement 33 · standardAP
1978-01-24Manufacturing (CMC) · Supplement 29 · standardAP
1977-06-03Manufacturing (CMC) · Supplement 31 · standardAP
1977-06-03Manufacturing (CMC) · Supplement 30 · standardAP
1976-09-15Labeling · Supplement 28 · standardAP
1976-08-03Manufacturing (CMC) · Supplement 26 · standardAP
1976-07-16Manufacturing (CMC) · Supplement 25 · standardAP
1976-05-25Manufacturing (CMC) · Supplement 27 · 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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