TEVA PHARMS USA FDA Approval ANDA 211510

ANDA 211510

TEVA PHARMS USA

FDA Drug Application

Application #211510

Application Sponsors

ANDA 211510TEVA PHARMS USA

Marketing Status

Discontinued001
Discontinued002
Discontinued003

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; ORIG1AP2018-10-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211510
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.005MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.025MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.05MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-23
        )

)

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