APPLICATION
ANDA073541
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-23
LATEST ACTION
2013-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 5MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEPrescription
CYCLOBENZAPRINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2013-04-11Labeling · Supplement 15 · standardAP
2006-04-06Labeling · Supplement 7AP
2006-04-06Manufacturing (CMC) · Supplement 6AP
2005-08-19Labeling · Supplement 5AP
1998-12-01Manufacturing (CMC) · Supplement 1AP
1995-05-23OriginalAP
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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