ZYDUS WORLDWIDE DMCC FDA Approval ANDA 214302

ANDA 214302

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #214302

Application Sponsors

ANDA 214302ZYDUS WORLDWIDE DMCC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006
None (Tentative Approval)007
None (Tentative Approval)008

Application Products

002TABLET;ORAL400MCG0SELEXIPAGSELEXIPAG
003TABLET;ORAL600MCG0SELEXIPAGSELEXIPAG
004TABLET;ORAL800MCG0SELEXIPAGSELEXIPAG
005TABLET;ORAL1000MC0SELEXIPAGSELEXIPAG
006TABLET;ORAL1200MCG0SELEXIPAGSELEXIPAG
007TABLET;ORAL1400MCG0SELEXIPAGSELEXIPAG
008TABLET;ORAL1600MCG0SELEXIPAGSELEXIPAG

FDA Submissions

UNKNOWN; ORIG1TA2022-05-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS WORLDWIDE DMCC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214302
            [companyName] => ZYDUS WORLDWIDE DMCC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"200MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"400MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"600MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"800MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"1000MC","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"1200MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"1400MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SELEXIPAG","activeIngredients":"SELEXIPAG","strength":"1600MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-03
        )

)

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