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FDA NDA · NDA212640

EXSERVAN

Sponsor: AQUESTIVE

APPLICATION
NDA212640
TYPE
NDA
ORIGINAL APPROVAL
2019-11-22
LATEST ACTION
2020-05-11
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Discontinued

Products

EXSERVAN · ReferenceDiscontinued
RILUZOLE 50MG · FILM · ORAL

Approval history

2020-05-11Labeling · Supplement 1 · standardLabelAP
2019-11-22Type 3 - New Dosage Form · 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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