APPLICATION
NDA016997
TYPE
NDA
ORIGINAL APPROVAL
1972-01-31
LATEST ACTION
2001-03-15
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
SERENTILDiscontinued
MESORIDAZINE BESYLATE EQ 25MG BASE/ML · CONCENTRATE · ORAL
Approval history
2000-09-06Labeling · Supplement 40 · standardAP
1997-03-14Manufacturing (CMC) · Supplement 39 · standardAP
1991-01-25Manufacturing (CMC) · Supplement 34 · standardAP
1989-08-15Manufacturing (CMC) · Supplement 32 · standardAP
1989-05-10Manufacturing (CMC) · Supplement 31 · standardAP
1987-08-20Manufacturing (CMC) · Supplement 29 · standardAP
1987-06-09Manufacturing (CMC) · Supplement 27 · standardAP
1987-06-09Manufacturing (CMC) · Supplement 25 · standardAP
1987-05-26Manufacturing (CMC) · Supplement 28 · standardAP
1987-04-23Manufacturing (CMC) · Supplement 26 · standardAP
1987-01-28Manufacturing (CMC) · Supplement 24 · standardAP
1986-11-24Manufacturing (CMC) · Supplement 21 · standardAP
1986-11-24Manufacturing (CMC) · Supplement 22 · standardAP
1986-11-24Manufacturing (CMC) · Supplement 20 · standardAP
1986-11-24Manufacturing (CMC) · Supplement 19 · standardAP
1986-06-10Manufacturing (CMC) · Supplement 18 · standardAP
1984-05-29Manufacturing (CMC) · Supplement 15 · standardAP
1982-11-05Labeling · Supplement 14 · standardAP
1982-09-13Manufacturing (CMC) · Supplement 13 · standardAP
1981-05-14Manufacturing (CMC) · Supplement 12 · standardAP
1980-12-10Labeling · Supplement 10 · standardAP
1980-05-13Manufacturing (CMC) · Supplement 8 · standardAP
1980-01-16Manufacturing (CMC) · Supplement 9 · standardAP
1976-05-25Manufacturing (CMC) · Supplement 7 · standardAP
1975-09-02Manufacturing (CMC) · Supplement 6 · standardAP
1975-03-31Labeling · Supplement 5 · standardAP
1975-03-31Manufacturing (CMC) · Supplement 3 · standardAP
1972-01-31Type 3 - New Dosage Form · 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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