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FDA NDA · NDA012365

SOMA COMPOUND

Sponsor: MEDA PHARMS

APPLICATION
NDA012365
TYPE
NDA
ORIGINAL APPROVAL
1960-09-12
LATEST ACTION
2013-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SOMA COMPOUNDDiscontinued
ASPIRIN 325MG, CARISOPRODOL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2013-01-31Labeling · Supplement 39 · standard — Label ↗AP
2009-11-17Labeling · Supplement 38 · unknown — Letter ↗AP
2009-04-01Labeling · Supplement 35 · standard — Letter ↗AP
2000-03-02Manufacturing (CMC) · Supplement 36 · standardAP
1993-10-25Manufacturing (CMC) · Supplement 33 · standardAP
1986-09-30Manufacturing (CMC) · Supplement 31 · standardAP
1986-01-10Labeling · Supplement 30AP
1983-07-11Manufacturing (CMC) · Supplement 29 · standardAP
1983-04-19Manufacturing (CMC) · Supplement 28 · standardAP
1983-04-05Manufacturing (CMC) · Supplement 26 · standardAP
1983-04-05Manufacturing (CMC) · Supplement 27 · standardAP
1983-03-11Manufacturing (CMC) · Supplement 24 · standardAP
1981-10-29Manufacturing (CMC) · Supplement 22 · standardAP
1980-02-15Labeling · Supplement 20AP
1974-12-12Labeling · Supplement 14AP
1974-12-12Manufacturing (CMC) · Supplement 12 · standardAP
1974-07-19Labeling · Supplement 13AP
1960-09-12Type 4 - New Combination · Original · standardAP
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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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