APPLICATION
ANDA089594
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARISOPRODOL AND ASPIRINDiscontinued
ASPIRIN 325MG, CARISOPRODOL 200MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 13 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2015-12-11Labeling · Supplement 9 · standardAP
2015-12-09Manufacturing (CMC) · Supplement 8AP
1997-11-26Manufacturing (CMC) · Supplement 2AP
1997-11-26Manufacturing (CMC) · Supplement 1AP
1989-03-31OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.