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FDA NDA · NDA211230

SUNOSI

solriamfetol

Sponsor: AXSOME MALTA

APPLICATION
NDA211230
TYPE
NDA
ORIGINAL APPROVAL
2019-03-20
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SUNOSI · ReferencePrescription
SOLRIAMFETOL HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
SUNOSI · ReferencePrescription
SOLRIAMFETOL HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL

Approval history

2023-06-28Labeling · Supplement 9 · standard — Letter ↗AP
2022-12-01Labeling · Supplement 7 · standard — Letter ↗AP
2021-10-20Labeling · Supplement 4 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 1 · standard — Label ↗AP
2019-03-20Type 1 - New Molecular Entity · Original · standard — Label ↗AP
2019-03-20Efficacy · 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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