ZYDUS FDA Approval ANDA 214803

ANDA 214803

ZYDUS

FDA Drug Application

Application #214803

Application Sponsors

ANDA 214803ZYDUS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 0.005MG BASE0LIOTHYRONINE SODIUMLIOTHYRONINE SODIUM
002TABLET;ORALEQ 0.025MG BASE0LIOTHYRONINE SODIUMLIOTHYRONINE SODIUM
003TABLET;ORALEQ 0.05MG BASE0LIOTHYRONINE SODIUMLIOTHYRONINE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-01-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214803
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.005MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.025MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.05MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-22
        )

)

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