ZYDUS PHARMS USA INC FDA Approval ANDA 217066

ANDA 217066

ZYDUS PHARMS USA INC

FDA Drug Application

Application #217066

Application Sponsors

ANDA 217066ZYDUS PHARMS USA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

001INJECTABLE;INJECTION100MCG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
002INJECTABLE;INJECTION200MCG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
003INJECTABLE;INJECTION500MCG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN; ORIG1TA2022-11-25STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217066
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"200MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"500MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-25
        )

)

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