APPLICATION
ANDA084488
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-11
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHOCARBAMOLDiscontinued
METHOCARBAMOL 500MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 50AP
1994-12-23Manufacturing (CMC) · Supplement 49AP
1994-10-11Manufacturing (CMC) · Supplement 48AP
1992-04-03Manufacturing (CMC) · Supplement 47AP
1992-04-03Manufacturing (CMC) · Supplement 45AP
1989-03-03Labeling · Supplement 44AP
1987-12-17Manufacturing (CMC) · Supplement 41AP
1987-04-06Manufacturing (CMC) · Supplement 42AP
1986-03-07Manufacturing (CMC) · Supplement 38AP
1985-11-19Manufacturing (CMC) · Supplement 33AP
1985-06-06Manufacturing (CMC) · Supplement 36AP
1984-03-23Manufacturing (CMC) · Supplement 34AP
1983-06-10Manufacturing (CMC) · Supplement 32AP
1975-07-11OriginalAP
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.