NDA 216196

AGIOS PHARMACEUTICALS INC

FDA Drug Application

Application #216196

Documents

• Label: 2022-02-17
• Letter: 2022-02-18
• Review: 2022-03-17

Application Sponsors

NDA 216196

AGIOS PHARMACEUTICALS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	5MG	0	PYRUKYND	MITAPIVAT
002	TABLET;ORAL	20MG	0	PYRUKYND	MITAPIVAT
003	TABLET;ORAL	50MG	0	PYRUKYND	MITAPIVAT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-02-17

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

AGIOS PHARMACEUTICALS INC

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            [ApplNo] => 216196
            [companyName] => AGIOS PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRUKYND","activeIngredients":"MITAPIVAT","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PYRUKYND","activeIngredients":"MITAPIVAT","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PYRUKYND","activeIngredients":"MITAPIVAT","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216196s000lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216196s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2022-02-17
        )

)