APPLICATION
NDA009698
TYPE
NDA
ORIGINAL APPROVAL
1955-04-28
LATEST ACTION
2001-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MILTOWN · ReferenceDiscontinued
MEPROBAMATE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MILTOWN · ReferenceDiscontinued
MEPROBAMATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-12-13Labeling · Supplement 35 · standardAP
2001-12-13Labeling · Supplement 36 · standardAP
1994-01-18Manufacturing (CMC) · Supplement 34 · standardAP
1993-08-09Manufacturing (CMC) · Supplement 33 · standardAP
1986-07-01Labeling · Supplement 29AP
1986-03-16Manufacturing (CMC) · Supplement 30 · standardAP
1981-07-29Manufacturing (CMC) · Supplement 24 · standardAP
1980-12-19Labeling · Supplement 23AP
1980-03-10Labeling · Supplement 22AP
1979-04-04Manufacturing (CMC) · Supplement 21 · standardAP
1978-06-12Labeling · Supplement 20AP
1975-01-15Manufacturing (CMC) · Supplement 8 · standardAP
1974-08-26REMS · Supplement 16 · standardAP
1955-04-28Type 5 - New Formulation or New Manufacturer · 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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