MERCK KGAA FDA Approval ANDA 076752

ANDA 076752

MERCK KGAA

FDA Drug Application

Application #076752

Application Sponsors

ANDA 076752MERCK KGAA

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006
Discontinued007
Discontinued008
Discontinued009
Discontinued010
Discontinued011

Application Products

001TABLET;ORAL0.025MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
002TABLET;ORAL0.05MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
003TABLET;ORAL0.075MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
004TABLET;ORAL0.088MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
005TABLET;ORAL0.1MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
006TABLET;ORAL0.112MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
007TABLET;ORAL0.125MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
008TABLET;ORAL0.15MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
009TABLET;ORAL0.175MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
010TABLET;ORAL0.2MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
011TABLET;ORAL0.3MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM

FDA Submissions

ORIG1AP2005-06-16
LABELING; LabelingSUPPL2AP2006-09-19
LABELING; LabelingSUPPL6AP2008-10-31

CDER Filings

MERCK KGAA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76752
            [companyName] => MERCK KGAA
            [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":"0.15MG","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":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.025MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.05MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.075MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.088MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.112MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.175MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVOTHYROXINE SODIUM","submission":"LEVOTHYROXINE SODIUM","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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