NDA 213498

JANSSEN PHARMACEUTICALS INC

FDA Drug Application

Application #213498

Documents

• Label: 2021-03-19
• Medication Guide: 2021-03-19
• Letter: 2021-03-19
• Review: 2021-04-16
• Label: 2021-10-28
• Medication Guide: 2021-10-28
• Letter: 2021-10-29

Application Sponsors

NDA 213498

JANSSEN PHARMACEUTICALS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009
• Prescription: 010

Application Products

001	TABLET;ORAL	2MG	2	PONVORY	PONESIMOD
002	TABLET;ORAL	3MG	2	PONVORY	PONESIMOD
003	TABLET;ORAL	4MG	2	PONVORY	PONESIMOD
004	TABLET;ORAL	5MG	2	PONVORY	PONESIMOD
005	TABLET;ORAL	6MG	2	PONVORY	PONESIMOD
006	TABLET;ORAL	7MG	2	PONVORY	PONESIMOD
007	TABLET;ORAL	8MG	2	PONVORY	PONESIMOD
008	TABLET;ORAL	9MG	2	PONVORY	PONESIMOD
009	TABLET;ORAL	10MG	2	PONVORY	PONESIMOD
010	TABLET;ORAL	20MG	2	PONVORY	PONESIMOD

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-03-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

JANSSEN PHARMACEUTICALS INC

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            [companyName] => JANSSEN PHARMACEUTICALS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/213498s000lbl.pdf#page=30"]
            [products] => [{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"9MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PONVORY","activeIngredients":"PONESIMOD","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/18\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213498s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213498s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213498Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-18
        )

)