STRIDES PHARMA FDA Approval ANDA 202330

ANDA 202330

STRIDES PHARMA

FDA Drug Application

Application #202330

Application Sponsors

ANDA 202330STRIDES PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET;ORAL5MG0BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE
002TABLET;ORAL10MG0BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE
003TABLET;ORAL15MG0BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE
004TABLET;ORAL30MG0BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE
005TABLET;ORAL7.5MG0BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE

FDA Submissions

ORIG1AP2014-08-25
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2015-06-30

Submissions Property Types

ORIG1Null15
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202330
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUSPIRONE HYDROCHLORIDE","activeIngredients":"BUSPIRONE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/30\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-06-30
        )

)

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