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FDA ANDA · ANDA080655

MEPROBAMATE

Sponsor: RISING

APPLICATION
ANDA080655
TYPE
ANDA
ORIGINAL APPROVAL
1972-07-12
LATEST ACTION
1997-05-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEPROBAMATEDiscontinued
MEPROBAMATE 400MG · TABLET · ORAL

Approval history

1997-05-05Manufacturing (CMC) · Supplement 89AP
1995-02-21Manufacturing (CMC) · Supplement 88AP
1989-12-22Labeling · Supplement 87AP
1989-10-18Labeling · Supplement 86AP
1989-08-04Labeling · Supplement 85AP
1988-03-28Labeling · Supplement 84AP
1983-11-30Manufacturing (CMC) · Supplement 81AP
1983-08-04Manufacturing (CMC) · Supplement 80AP
1983-08-04Manufacturing (CMC) · Supplement 79AP
1982-10-18Manufacturing (CMC) · Supplement 78AP
1982-10-18Manufacturing (CMC) · Supplement 76AP
1982-10-18Manufacturing (CMC) · Supplement 77AP
1982-05-24Manufacturing (CMC) · Supplement 71AP
1982-05-18Manufacturing (CMC) · Supplement 62AP
1982-05-18Manufacturing (CMC) · Supplement 42AP
1982-05-18Manufacturing (CMC) · Supplement 69AP
1982-05-18Manufacturing (CMC) · Supplement 75AP
1982-05-18Manufacturing (CMC) · Supplement 73AP
1982-05-18Manufacturing (CMC) · Supplement 61AP
1972-07-12OriginalAP
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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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