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FDA NDA · NDA209203

DUZALLO

Sponsor: IRONWOOD PHARMS INC

APPLICATION
NDA209203
TYPE
NDA
ORIGINAL APPROVAL
2017-08-18
LATEST ACTION
2017-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DUZALLO · ReferenceDiscontinued
ALLOPURINOL 200MG, LESINURAD 200MG · TABLET · ORAL
DUZALLO · ReferenceDiscontinued
ALLOPURINOL 300MG, LESINURAD 200MG · TABLET · ORAL

Approval history

2017-08-18Type 4 - New Combination · Original · standardLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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