PRINSTON INC FDA Approval ANDA 201781

ANDA 201781

PRINSTON INC

FDA Drug Application

Application #201781

Application Sponsors

ANDA 201781PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL7.5MG0TEMAZEPAMTEMAZEPAM
002CAPSULE;ORAL15MG0TEMAZEPAMTEMAZEPAM
003CAPSULE;ORAL22.5MG0TEMAZEPAMTEMAZEPAM
004CAPSULE;ORAL30MG0TEMAZEPAMTEMAZEPAM

FDA Submissions

N/A; Not ApplicableORIG1AP2015-06-04

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201781
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"22.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-06-04
        )

)

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