ANDA 211510

TEVA PHARMS USA

FDA Drug Application

Application #211510

Application Sponsors

ANDA 211510

TEVA PHARMS USA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	EQ 0.005MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM
002	TABLET;ORAL	EQ 0.025MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM
003	TABLET;ORAL	EQ 0.05MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)