TEVA PHARMS USA INC FDA Approval ANDA 211044

ANDA 211044

TEVA PHARMS USA INC

FDA Drug Application

Application #211044

Application Sponsors

ANDA 211044TEVA PHARMS USA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005

Application Products

002TABLET;ORAL1MG0RIOCIGUATRIOCIGUAT
003TABLET;ORAL1.5MG0RIOCIGUATRIOCIGUAT
004TABLET;ORAL2MG0RIOCIGUATRIOCIGUAT
005TABLET;ORAL2.5MG0RIOCIGUATRIOCIGUAT

FDA Submissions

UNKNOWN; ORIG1TA2022-03-30STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211044
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIOCIGUAT","activeIngredients":"RIOCIGUAT","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)

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