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FDA ANDA · ANDA084928

METHOCARBAMOL

Sponsor: IMPAX LABS

APPLICATION
ANDA084928
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-20
LATEST ACTION
1989-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHOCARBAMOLDiscontinued
METHOCARBAMOL 750MG · TABLET · ORAL

Approval history

1989-09-28Labeling · Supplement 31AP
1988-12-19Labeling · Supplement 30AP
1988-06-10Labeling · Supplement 29AP
1988-04-18Manufacturing (CMC) · Supplement 26AP
1987-11-14Manufacturing (CMC) · Supplement 28AP
1987-09-03Manufacturing (CMC) · Supplement 27AP
1987-07-02Manufacturing (CMC) · Supplement 25AP
1986-08-15Manufacturing (CMC) · Supplement 23AP
1986-08-15Manufacturing (CMC) · Supplement 24AP
1976-08-20OriginalAP
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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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