← FDA DRUG APPROVALS

FDA ANDA · ANDA200958

METHOCARBAMOL

Sponsor: BOSTAL

APPLICATION
ANDA200958
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-21
LATEST ACTION
2022-10-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METHOCARBAMOLPrescription
METHOCARBAMOL 750MG · TABLET · ORAL
METHOCARBAMOLPrescription
METHOCARBAMOL 1GM · TABLET · ORAL
METHOCARBAMOLPrescription
METHOCARBAMOL 500MG · TABLET · ORAL

Approval history

2022-10-12Manufacturing (CMC) · Supplement 20 · unknownAP
2022-07-15Manufacturing (CMC) · Supplement 19 · unknownAP
2011-10-21Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →