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FDA ANDA · ANDA077797

CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor: PRINSTON INC

APPLICATION
ANDA077797
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-28
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 10 · standardAP
2009-01-06Labeling · Supplement 4AP
2008-08-07Labeling · Supplement 2AP
2007-02-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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