APPLICATION
NDA011792
TYPE
NDA
ORIGINAL APPROVAL
1959-04-09
LATEST ACTION
2019-04-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Discontinued, Prescription
Products
SOMA · ReferenceDiscontinued
CARISOPRODOL 250MG · CAPSULE · ORAL
SOMA · ReferencePrescription
CARISOPRODOL 350MG · TABLET · ORAL
SOMA · ReferencePrescription
CARISOPRODOL 250MG · TABLET · ORAL
Approval history
2009-11-06Manufacturing (CMC) · Supplement 42AP
1999-12-29Manufacturing (CMC) · Supplement 36 · standardAP
1994-03-02Manufacturing (CMC) · Supplement 31 · standardAP
1993-10-25Manufacturing (CMC) · Supplement 32 · standardAP
1987-11-27Manufacturing (CMC) · Supplement 26 · standardAP
1987-11-10Manufacturing (CMC) · Supplement 30 · standardAP
1987-09-01Manufacturing (CMC) · Supplement 29 · standardAP
1986-10-27Labeling · Supplement 28AP
1986-04-30Manufacturing (CMC) · Supplement 27 · standardAP
1983-04-19Manufacturing (CMC) · Supplement 25 · standardAP
1983-03-18Manufacturing (CMC) · Supplement 24 · standardAP
1983-03-18Manufacturing (CMC) · Supplement 23 · standardAP
1981-10-27Manufacturing (CMC) · Supplement 21 · standardAP
1979-12-05Manufacturing (CMC) · Supplement 18 · standardAP
1979-11-30Manufacturing (CMC) · Supplement 19 · standardAP
1979-04-13Manufacturing (CMC) · Supplement 20 · standardAP
1975-05-20Labeling · Supplement 17AP
1974-12-13Manufacturing (CMC) · Supplement 14 · standardAP
1974-11-08Labeling · Supplement 16AP
1974-07-19Labeling · Supplement 15AP
1959-04-09Type 1 - New Molecular Entity · 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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