ACTIVE SUBSTANCE / INN

SOLRIAMFETOL

Brand name(s): Sunosi, SOLRIAMFETOL

FDA LISTED

EMA LISTED

AUTHORISED

NONE (TENTATIVE APPROVAL)

ANDA218654

Narcolepsy;Sleep Apnea, Obstructive

ACTIVE SUBSTANCE

Solriamfetol

REGULATORS

FDA · EMA

SPONSORS / MAH

Atnahs Pharma Netherlands B.V., HETERO LABS LIMITED

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
SOLRIAMFETOL	ANDA218654	HETERO LABS LIMITED	None (Tentative Approval)

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Sunosi	Atnahs Pharma Netherlands B.V.	Authorised	16/01/2020	Narcolepsy;Sleep Apnea, Obstructive

FULL INTELLIGENCE ON SOLRIAMFETOL