SUN PHARM INDS LTD FDA Approval ANDA 078722

ANDA 078722

SUN PHARM INDS LTD

FDA Drug Application

Application #078722

Application Sponsors

ANDA 078722SUN PHARM INDS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL5MG0CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
002TABLET;ORAL7.5MG0CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
003TABLET;ORAL10MG0CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2008-05-12
LABELING; LabelingSUPPL3AP2013-04-11STANDARD

Submissions Property Types

SUPPL3Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78722
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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