APPLICATION
NDA010028
TYPE
NDA
ORIGINAL APPROVAL
1955-07-26
LATEST ACTION
1988-07-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EQUANILDiscontinued
MEPROBAMATE 400MG · TABLET · ORAL
EQUANILDiscontinued
MEPROBAMATE 200MG · TABLET · ORAL
Approval history
1988-07-27Manufacturing (CMC) · Supplement 26 · priorityAP
1988-07-27Manufacturing (CMC) · Supplement 27 · priorityAP
1988-01-05Manufacturing (CMC) · Supplement 24 · priorityAP
1987-02-02Manufacturing (CMC) · Supplement 23 · priorityAP
1986-04-08Labeling · Supplement 21 · priorityAP
1981-01-16Labeling · Supplement 19 · priorityAP
1979-07-24Manufacturing (CMC) · Supplement 18 · priorityAP
1978-03-30Labeling · Supplement 17 · priorityAP
1977-08-18Manufacturing (CMC) · Supplement 16 · priorityAP
1976-11-09Labeling · Supplement 15 · priorityAP
1975-06-23Manufacturing (CMC) · Supplement 13 · priorityAP
1955-07-26Type 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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