ANDA 214302

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #214302

Documents

• Letter: 2022-08-25
• Letter: 2023-01-10

Application Sponsors

ANDA 214302

ZYDUS 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

001	TABLET;ORAL	0.2MG	0	SELEXIPAG	SELEXIPAG
002	TABLET;ORAL	400MCG	0	SELEXIPAG	SELEXIPAG
003	TABLET;ORAL	600MCG	0	SELEXIPAG	SELEXIPAG
004	TABLET;ORAL	800MCG	0	SELEXIPAG	SELEXIPAG
005	TABLET;ORAL	1000MC	0	SELEXIPAG	SELEXIPAG
006	TABLET;ORAL	1200MCG	0	SELEXIPAG	SELEXIPAG
007	TABLET;ORAL	1400MCG	0	SELEXIPAG	SELEXIPAG
008	TABLET;ORAL	1600MCG	0	SELEXIPAG	SELEXIPAG

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-05-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB
008	Prescription	AB

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
        )

)