APPLICATION
ANDA040118
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-16
LATEST ACTION
2023-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATEDiscontinued
ASPIRIN 325MG, CARISOPRODOL 200MG, CODEINE PHOSPHATE 16MG · TABLET · ORAL
Approval history
2023-12-15Labeling · Supplement 24 · standardAP
2021-04-28Labeling · Supplement 21 · standardAP
2021-03-04Labeling · Supplement 20 · standardAP
2019-10-16Labeling · Supplement 19 · standardAP
2018-09-20Labeling · Supplement 18 · standardAP
2018-09-18REMS · Supplement 17AP
2017-08-29Labeling · Supplement 16 · standardAP
2013-07-30Labeling · Supplement 13 · standardAP
2013-07-30Labeling · Supplement 14 · standardAP
2011-06-21Labeling · Supplement 12AP
2008-08-13Labeling · Supplement 11AP
2000-02-02Manufacturing (CMC) · Supplement 5AP
1999-02-01Manufacturing (CMC) · Supplement 4AP
1997-04-10Manufacturing (CMC) · Supplement 3AP
1997-04-10Manufacturing (CMC) · Supplement 1AP
1997-04-10Manufacturing (CMC) · Supplement 2AP
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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