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FDA NDA · NDA212950

RUKOBIA

fostemsavir tromethamine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA212950
TYPE
NDA
ORIGINAL APPROVAL
2020-07-02
LATEST ACTION
2024-02-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

RUKOBIA · ReferencePrescription
FOSTEMSAVIR TROMETHAMINE EQ 600MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-02-13Labeling · Supplement 4 · standard — Letter ↗AP
2022-01-24Efficacy · Supplement 2 · standardAP
2020-07-02Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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