APPLICATION
NDA011790
TYPE
NDA
ORIGINAL APPROVAL
1959-06-10
LATEST ACTION
2014-08-12
ROUTE
INTRAMUSCULAR, INTRAVENOUS, IM-IV
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ROBAXIN · ReferencePrescription
METHOCARBAMOL 1GM/10ML (100MG/ML) · SOLUTION · IM-IV
Approval history
2014-08-12Manufacturing (CMC) · Supplement 51 · standardAP
2014-04-29Manufacturing (CMC) · Supplement 50 · standardAP
2001-02-28Manufacturing (CMC) · Supplement 42 · standardAP
1999-12-29Manufacturing (CMC) · Supplement 41 · standardAP
1998-04-22Manufacturing (CMC) · Supplement 40 · standardAP
1990-12-11Manufacturing (CMC) · Supplement 38 · standardAP
1988-12-02Manufacturing (CMC) · Supplement 37 · standardAP
1987-01-22Manufacturing (CMC) · Supplement 36 · standardAP
1987-01-07Manufacturing (CMC) · Supplement 35 · standardAP
1986-01-03Manufacturing (CMC) · Supplement 34 · standardAP
1983-06-20Labeling · Supplement 32AP
1982-12-16Manufacturing (CMC) · Supplement 33 · standardAP
1982-09-03Manufacturing (CMC) · Supplement 30 · standardAP
1982-01-22Labeling · Supplement 28AP
1981-09-29Manufacturing (CMC) · Supplement 29 · standardAP
1981-06-10Labeling · Supplement 27AP
1980-05-23Manufacturing (CMC) · Supplement 24 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 25 · standardAP
1980-05-01Manufacturing (CMC) · Supplement 23 · standardAP
1980-01-03Manufacturing (CMC) · Supplement 26 · standardAP
1979-09-17Manufacturing (CMC) · Supplement 22 · standardAP
1976-03-11Manufacturing (CMC) · Supplement 12 · standardAP
1959-06-10Type 3 - New Dosage Form · Original · standardAP
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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