TEVA PHARMS USA INC FDA Approval ANDA 211369

ANDA 211369

TEVA PHARMS USA INC

FDA Drug Application

Application #211369

Application Sponsors

ANDA 211369TEVA PHARMS USA INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL0.075MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
002CAPSULE;ORAL0.15MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-10-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211369
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.075MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-28
        )

)

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