APPLICATION
ANDA091281
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-31
LATEST ACTION
2024-12-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-12-17Labeling · Supplement 16 · standardAP
2023-10-13Labeling · Supplement 10 · standardAP
2018-03-13Bioequivalence · Supplement 6AP
2014-11-06Manufacturing (CMC) · Supplement 2AP
2013-01-31OriginalAP
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.
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