APPLICATION
ANDA084756
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-23
LATEST ACTION
2007-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHOCARBAMOLDiscontinued
METHOCARBAMOL 500MG · TABLET · ORAL
METHOCARBAMOLDiscontinued
METHOCARBAMOL 750MG · TABLET · ORAL
Approval history
2007-11-01Labeling · Supplement 11AP
2003-05-31Manufacturing (CMC) · Supplement 5AP
2003-03-31Labeling · Supplement 7AP
2003-03-31Manufacturing (CMC) · Supplement 6AP
2000-08-10Manufacturing (CMC) · Supplement 4AP
1983-07-06Manufacturing (CMC) · Supplement 3AP
1976-11-23OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.