← FDA DRUG APPROVALS

FDA ANDA · ANDA084277

METHOCARBAMOL

Sponsor: ANI PHARMS

APPLICATION
ANDA084277
TYPE
ANDA
ORIGINAL APPROVAL
1977-03-14
LATEST ACTION
2007-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHOCARBAMOLDiscontinued
METHOCARBAMOL 500MG · TABLET · ORAL

Approval history

2007-09-28Labeling · Supplement 48AP
2002-11-13Manufacturing (CMC) · Supplement 43AP
2001-04-25Manufacturing (CMC) · Supplement 42AP
1999-08-13Manufacturing (CMC) · Supplement 40AP
1999-08-13Manufacturing (CMC) · Supplement 41AP
1998-09-22Labeling · Supplement 38AP
1998-09-22Manufacturing (CMC) · Supplement 36AP
1998-09-22Manufacturing (CMC) · Supplement 37AP
1991-08-07Manufacturing (CMC) · Supplement 34AP
1991-01-28Manufacturing (CMC) · Supplement 35AP
1990-06-29Manufacturing (CMC) · Supplement 33AP
1988-09-07Manufacturing (CMC) · Supplement 31AP
1988-04-15Labeling · Supplement 29AP
1987-05-18Manufacturing (CMC) · Supplement 26AP
1987-05-18Manufacturing (CMC) · Supplement 27AP
1987-05-18Manufacturing (CMC) · Supplement 25AP
1987-02-26Manufacturing (CMC) · Supplement 24AP
1986-05-12Manufacturing (CMC) · Supplement 20AP
1986-05-12Manufacturing (CMC) · Supplement 19AP
1985-08-02Manufacturing (CMC) · Supplement 22AP
1985-08-02Manufacturing (CMC) · Supplement 21AP
1982-07-01Manufacturing (CMC) · Supplement 14AP
1982-07-01Manufacturing (CMC) · Supplement 15AP
1977-03-14OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →