APPLICATION
NDA011011
TYPE
NDA
ORIGINAL APPROVAL
1957-07-16
LATEST ACTION
2019-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ROBAXIN-750 · ReferenceDiscontinued
METHOCARBAMOL 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ROBAXIN · ReferenceDiscontinued
METHOCARBAMOL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2015-03-09Manufacturing (CMC) · Supplement 77 · standardAP
1998-04-22Manufacturing (CMC) · Supplement 69 · standardAP
1990-08-21Manufacturing (CMC) · Supplement 66 · standardAP
1989-01-06Manufacturing (CMC) · Supplement 64 · standardAP
1987-01-28Manufacturing (CMC) · Supplement 63 · standardAP
1986-04-16Manufacturing (CMC) · Supplement 61 · standardAP
1986-04-16Manufacturing (CMC) · Supplement 62 · standardAP
1985-10-25Labeling · Supplement 60AP
1985-04-29Manufacturing (CMC) · Supplement 59 · standardAP
1985-04-29Manufacturing (CMC) · Supplement 58 · standardAP
1984-06-27Manufacturing (CMC) · Supplement 57 · standardAP
1983-04-07Manufacturing (CMC) · Supplement 54 · standardAP
1983-01-25Manufacturing (CMC) · Supplement 55 · standardAP
1982-10-18Manufacturing (CMC) · Supplement 53 · standardAP
1982-10-01Manufacturing (CMC) · Supplement 52 · standardAP
1982-07-15Manufacturing (CMC) · Supplement 42 · standardAP
1982-03-15Manufacturing (CMC) · Supplement 49 · standardAP
1982-01-18Manufacturing (CMC) · Supplement 44 · standardAP
1982-01-18Manufacturing (CMC) · Supplement 50 · standardAP
1981-12-24Manufacturing (CMC) · Supplement 47 · standardAP
1981-12-24Manufacturing (CMC) · Supplement 46 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 48 · standardAP
1981-12-07Labeling · Supplement 39AP
1981-11-02Manufacturing (CMC) · Supplement 43 · standardAP
1981-10-28Labeling · Supplement 38AP
1981-01-22Manufacturing (CMC) · Supplement 41 · standardAP
1981-01-22Manufacturing (CMC) · Supplement 40 · standardAP
1980-02-11Manufacturing (CMC) · Supplement 32 · standardAP
1979-07-24Manufacturing (CMC) · Supplement 31 · standardAP
1979-05-21Manufacturing (CMC) · Supplement 22 · standardAP
1979-05-21Labeling · Supplement 20AP
1979-05-21Labeling · Supplement 19AP
1976-03-10Manufacturing (CMC) · Supplement 18 · standardAP
1975-05-01Manufacturing (CMC) · Supplement 17 · standardAP
1975-04-29Manufacturing (CMC) · Supplement 12 · standardAP
1975-04-29Manufacturing (CMC) · Supplement 13 · standardAP
1974-12-09Labeling · Supplement 11AP
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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