APPLICATION
ANDA078218
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-18
LATEST ACTION
2015-06-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 10MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 5MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG · TABLET · ORAL
Approval history
2015-06-19Labeling · Supplement 3AP
2013-04-11Labeling · Supplement 6 · standardAP
2008-04-18OriginalAP
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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