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FDA ANDA · ANDA085721

MEPROBAMATE

Sponsor: WATSON LABS

APPLICATION
ANDA085721
TYPE
ANDA
ORIGINAL APPROVAL
1977-07-13
LATEST ACTION
1999-04-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEPROBAMATEDiscontinued
MEPROBAMATE 400MG · TABLET · ORAL

Approval history

1999-04-20Manufacturing (CMC) · Supplement 33AP
1999-01-21Manufacturing (CMC) · Supplement 32AP
1997-07-18Manufacturing (CMC) · Supplement 30AP
1997-07-18Manufacturing (CMC) · Supplement 29AP
1997-07-18Manufacturing (CMC) · Supplement 31AP
1991-04-22Labeling · Supplement 28AP
1989-02-02Manufacturing (CMC) · Supplement 27AP
1989-02-02Manufacturing (CMC) · Supplement 25AP
1988-04-14Labeling · Supplement 24AP
1987-12-24Manufacturing (CMC) · Supplement 22AP
1987-07-21Manufacturing (CMC) · Supplement 21AP
1987-07-21Manufacturing (CMC) · Supplement 20AP
1986-12-10Manufacturing (CMC) · Supplement 18AP
1983-01-18Manufacturing (CMC) · Supplement 14AP
1977-07-13OriginalAP
VIEW ON DRUGS@FDA ↗

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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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