APPLICATION
ANDA072854
TYPE
ANDA
ORIGINAL APPROVAL
1991-11-19
LATEST ACTION
2026-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 10MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-05-13Manufacturing (CMC) · Supplement 24 · unknownAP
2015-07-23Labeling · Supplement 23 · standardAP
2006-02-03Manufacturing (CMC) · Supplement 14AP
2006-02-03Labeling · Supplement 15AP
2005-06-28Labeling · Supplement 12AP
2001-08-27Manufacturing (CMC) · Supplement 9AP
2000-01-21Manufacturing (CMC) · Supplement 8AP
1999-05-05Manufacturing (CMC) · Supplement 7AP
1999-02-05Labeling · Supplement 5AP
1999-02-05Manufacturing (CMC) · Supplement 6AP
1999-02-05Manufacturing (CMC) · Supplement 4AP
1997-09-26Manufacturing (CMC) · Supplement 3AP
1994-04-22Labeling · Supplement 2AP
1994-01-24Manufacturing (CMC) · Supplement 1AP
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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