ANDA 210831

AMNEAL PHARMS LLC

FDA Drug Application

Application #210831

Application Sponsors

ANDA 210831

AMNEAL PHARMS LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 007
• Discontinued: 008
• Discontinued: 009
• Discontinued: 010
• Discontinued: 011
• Discontinued: 012

Application Products

001	TABLET;ORAL	0.025MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
002	TABLET;ORAL	0.05MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
003	TABLET;ORAL	0.075MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
004	TABLET;ORAL	0.088MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
005	TABLET;ORAL	0.1MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
006	TABLET;ORAL	0.112MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
007	TABLET;ORAL	0.125MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
008	TABLET;ORAL	0.137MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
009	TABLET;ORAL	0.15MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
010	TABLET;ORAL	0.175MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
011	TABLET;ORAL	0.2MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
012	TABLET;ORAL	0.3MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210831
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.025MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.05MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.075MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.088MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.112MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.137MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.175MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-19
        )

)