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PYRUKYND

NDA · New Drug Application · Sponsor: AGIOS PHARMS INC · Approved 2022-02-17

Drug application

FDA Application #

NDA216196

Application type

New Drug Application

Brand name

PYRUKYND

Generic name

MITAPIVAT

Active ingredients

MITAPIVAT SULFATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AGIOS PHARMS INC

Manufacturer

Agios Pharmaceuticals, Inc.

First approval

2022-02-17

Source

Authoritative

Drugs@FDA application overview

Machine

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