NDA 210632

FRESENIUS KABI USA

FDA Drug Application

Application #210632

Documents

• Label: 2019-04-12
• Letter: 2019-04-12
• Review: 2019-12-17
• Summary Review: 2019-12-17

Application Sponsors

NDA 210632

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	100MCG/5ML (20MCG/ML)	1	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
002	SOLUTION;INTRAVENOUS	200MCG/5ML (40MCG/ML)	1	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
003	SOLUTION;INTRAVENOUS	500MCG/5ML (100MCG/ML)	1	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2019-04-11

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

FRESENIUS KABI USA

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    [0] => Array
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            [ApplNo] => 210632
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG\/5ML (20MCG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"200MCG\/5ML (40MCG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"500MCG\/5ML (100MCG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/11\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210632s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2019-04-11
        )

)