APPLICATION
ANDA040116
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-25
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 16 · standardAP
2021-04-28Labeling · Supplement 14 · standardAP
2013-07-30Labeling · Supplement 12 · standardAP
2011-06-20Labeling · Supplement 11AP
2001-01-01Supplement · Supplement 100AP
2000-02-02Manufacturing (CMC) · Supplement 5AP
1998-12-14Manufacturing (CMC) · Supplement 4AP
1997-01-31Manufacturing (CMC) · Supplement 3AP
1997-01-31Manufacturing (CMC) · Supplement 1AP
1997-01-31Manufacturing (CMC) · Supplement 2AP
1996-04-25OriginalAP
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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