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FDA ANDA · ANDA090864

CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor: PAR PHARM INC

APPLICATION
ANDA090864
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

CYCLOBENZAPRINE HYDROCHLORIDENone (Tentative Approval)
CYCLOBENZAPRINE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
CYCLOBENZAPRINE HYDROCHLORIDENone (Tentative Approval)
CYCLOBENZAPRINE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2013-07-26OriginalTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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