JIANGSU HENGRUI MED FDA Approval ANDA 091008

ANDA 091008

JIANGSU HENGRUI MED

FDA Drug Application

Application #091008

Application Sponsors

ANDA 091008JIANGSU HENGRUI MED

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

ORIG1AP2017-10-26

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

JIANGSU HENGRUI MED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91008
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"400MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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