← FDA DRUG APPROVALS

FDA NDA · NDA213687

DOJOLVI

triheptanoin

Sponsor: ULTRAGENYX PHARM INC

APPLICATION
NDA213687
TYPE
NDA
ORIGINAL APPROVAL
2020-06-30
LATEST ACTION
2023-10-30
ROUTE
ORAL
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription

Products

DOJOLVI · ReferencePrescription
TRIHEPTANOIN 100% w/w · LIQUID · ORAL

Approval history

2023-10-30Labeling · Supplement 3 · standard — Label ↗AP
2020-06-30Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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