ZHEJIANG YONGTAI FDA Approval ANDA 213603

ANDA 213603

ZHEJIANG YONGTAI

FDA Drug Application

Application #213603

Application Sponsors

ANDA 213603ZHEJIANG YONGTAI

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL100MG0GABAPENTINGABAPENTIN
002CAPSULE;ORAL300MG0GABAPENTINGABAPENTIN
003CAPSULE;ORAL400MG0GABAPENTINGABAPENTIN

FDA Submissions

UNKNOWN; ORIG1AP2020-08-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZHEJIANG YONGTAI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213603
            [companyName] => ZHEJIANG YONGTAI
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-17
        )

)

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