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FDA ANDA · ANDA084276

METHOCARBAMOL

Sponsor: ANI PHARMS

APPLICATION
ANDA084276
TYPE
ANDA
ORIGINAL APPROVAL
1977-01-04
LATEST ACTION
2007-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHOCARBAMOLDiscontinued
METHOCARBAMOL 750MG · TABLET · ORAL

Approval history

2007-09-28Labeling · Supplement 52AP
2002-11-13Manufacturing (CMC) · Supplement 47AP
2001-04-25Manufacturing (CMC) · Supplement 46AP
1999-06-08Manufacturing (CMC) · Supplement 45AP
1999-06-08Manufacturing (CMC) · Supplement 44AP
1998-09-22Manufacturing (CMC) · Supplement 39AP
1998-09-22Manufacturing (CMC) · Supplement 41AP
1998-09-22Labeling · Supplement 42AP
1998-09-22Manufacturing (CMC) · Supplement 40AP
1990-06-29Manufacturing (CMC) · Supplement 36AP
1988-09-07Manufacturing (CMC) · Supplement 35AP
1988-09-07Manufacturing (CMC) · Supplement 33AP
1988-09-07Manufacturing (CMC) · Supplement 34AP
1988-09-02Bioequivalence · Supplement 32AP
1987-02-26Manufacturing (CMC) · Supplement 31AP
1985-08-16Manufacturing (CMC) · Supplement 25AP
1985-08-02Manufacturing (CMC) · Supplement 29AP
1985-08-02Manufacturing (CMC) · Supplement 27AP
1985-08-02Manufacturing (CMC) · Supplement 28AP
1985-08-02Manufacturing (CMC) · Supplement 26AP
1984-04-04Manufacturing (CMC) · Supplement 24AP
1983-11-16Manufacturing (CMC) · Supplement 20AP
1982-12-16Manufacturing (CMC) · Supplement 23AP
1982-04-05Manufacturing (CMC) · Supplement 19AP
1977-01-04OriginalAP
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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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