ANDA 090864

PAR PHARM INC

FDA Drug Application

Application #090864

Application Sponsors

ANDA 090864

PAR PHARM INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	CAPSULE, EXTENDED RELEASE; ORAL	15MG	0	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE; ORAL	30MG	0	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE

FDA Submissions

ORIG

1

TA

2013-07-26

Submissions Property Types

ORIG

1

Null

19

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90864
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)