ASCENT PHARMS INC FDA Approval ANDA 214956

ANDA 214956

ASCENT PHARMS INC

FDA Drug Application

Application #214956

Application Sponsors

ANDA 214956ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2021-05-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214956
            [companyName] => ASCENT PHARMS INC
            [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":"05\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-10
        )

)

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