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FDA NDA · NDA014547

MEPROBAMATE

Sponsor: SANDOZ

APPLICATION
NDA014547
TYPE
NDA
ORIGINAL APPROVAL
1963-07-26
LATEST ACTION
2001-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEPROBAMATEDiscontinued
MEPROBAMATE 200MG · TABLET · ORAL
MEPROBAMATEDiscontinued
MEPROBAMATE 400MG · TABLET · ORAL

Approval history

2001-10-18Labeling · Supplement 16 · standardAP
1994-11-01Manufacturing (CMC) · Supplement 15 · standardAP
1987-11-16Manufacturing (CMC) · Supplement 7 · standardAP
1986-10-09Manufacturing (CMC) · Supplement 5 · standardAP
1986-08-18Labeling · Supplement 6AP
1981-02-10Labeling · Supplement 3AP
1963-07-26Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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