HETERO LABS LTD V FDA Approval ANDA 204316

ANDA 204316

HETERO LABS LTD V

FDA Drug Application

Application #204316

Application Sponsors

ANDA 204316HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORALEQ 25MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
002TABLET;ORALEQ 50MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
003TABLET;ORALEQ 100MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
004TABLET;ORALEQ 200MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
005TABLET;ORALEQ 300MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
006TABLET;ORALEQ 400MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-16

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204316
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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