AMNEAL FDA Approval ANDA 215456

ANDA 215456

AMNEAL

FDA Drug Application

Application #215456

Application Sponsors

ANDA 215456AMNEAL

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL1MG0THIOTHIXENETHIOTHIXENE
002CAPSULE;ORAL2MG0THIOTHIXENETHIOTHIXENE
003CAPSULE;ORAL5MG0THIOTHIXENETHIOTHIXENE
004CAPSULE;ORAL10MG0THIOTHIXENETHIOTHIXENE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215456
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-28
        )

)

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