APPLICATION
ANDA086988
TYPE
ANDA
ORIGINAL APPROVAL
1979-10-29
LATEST ACTION
2025-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHOCARBAMOLPrescription
METHOCARBAMOL 500MG · TABLET · ORAL
METHOCARBAMOLPrescription
METHOCARBAMOL 750MG · TABLET · ORAL
Approval history
2025-04-08Labeling · Supplement 15 · standardAP
2012-09-28Manufacturing (CMC) · Supplement 9AP
1988-11-08Manufacturing (CMC) · Supplement 7AP
1988-11-08Manufacturing (CMC) · Supplement 5AP
1988-11-08Manufacturing (CMC) · Supplement 6AP
1986-06-19Manufacturing (CMC) · Supplement 3AP
1986-06-09Manufacturing (CMC) · Supplement 4AP
1979-10-29OriginalAP
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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