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FDA ANDA · ANDA040860
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
Sponsor: INGENUS PHARMS NJ
APPLICATION
ANDA040860
TYPE
ANDA
ORIGINAL APPROVAL
2010-01-07
LATEST ACTION
2026-06-18
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
2026-06-18REMS · Supplement 15AP
2025-12-22Labeling · Supplement 14 · standardAP
2024-11-21Labeling · Supplement 13 · standardAP
2024-10-31REMS · Supplement 12AP
2024-10-10Labeling · Supplement 11 · standardAP
2024-02-22Labeling · Supplement 10 · standardAP
2024-02-22Labeling · Supplement 9 · standardAP
2021-05-07Labeling · Supplement 7 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2019-10-07Labeling · Supplement 5 · standardAP
2018-09-21Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 3AP
2017-08-29Labeling · Supplement 2 · standardAP
2017-08-29Labeling · Supplement 1 · 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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