ZYDUS PHARMS FDA Approval ANDA 213003

ANDA 213003

ZYDUS PHARMS

FDA Drug Application

Application #213003

Application Sponsors

ANDA 213003ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL0.125MG0TRIAZOLAMTRIAZOLAM
002TABLET;ORAL0.25MG0TRIAZOLAMTRIAZOLAM

FDA Submissions

UNKNOWN; ORIG1AP2022-12-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213003
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAZOLAM","activeIngredients":"TRIAZOLAM","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAZOLAM","activeIngredients":"TRIAZOLAM","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-28
        )

)

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