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FDA ANDA · ANDA083308

MEPROBAMATE

Sponsor: WATSON LABS

APPLICATION
ANDA083308
TYPE
ANDA
ORIGINAL APPROVAL
1973-05-03
LATEST ACTION
2004-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEPROBAMATE · ReferenceDiscontinued
MEPROBAMATE 400MG · TABLET · ORAL

Approval history

2004-11-22Labeling · Supplement 51AP
2001-04-25Manufacturing (CMC) · Supplement 49AP
1998-01-20Manufacturing (CMC) · Supplement 47AP
1998-01-20Manufacturing (CMC) · Supplement 46AP
1991-08-07Manufacturing (CMC) · Supplement 43AP
1991-01-28Manufacturing (CMC) · Supplement 44AP
1990-06-29Manufacturing (CMC) · Supplement 42AP
1989-02-08Labeling · Supplement 41AP
1988-10-21Manufacturing (CMC) · Supplement 39AP
1988-10-21Manufacturing (CMC) · Supplement 38AP
1988-10-13Labeling · Supplement 66AP
1988-10-13Labeling · Supplement 40AP
1982-06-02Manufacturing (CMC) · Supplement 35AP
1982-06-02Manufacturing (CMC) · Supplement 36AP
1973-05-03OriginalAP
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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