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Last Updated: December 22, 2024

Pharmaceutical drugs supplied by: NextWave Pharmaceuticals, Inc

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NextWave Pharmaceuticals, Inc

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960	NDA	NextWave Pharmaceuticals, Inc	24478-074-01	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01)	2016-04-18
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960	NDA	NextWave Pharmaceuticals, Inc	24478-075-01	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-01)	2016-04-18
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960	NDA	NextWave Pharmaceuticals, Inc	24478-076-01	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-01)	2016-04-18
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147	NDA	NextWave Pharmaceuticals, Inc	24478-102-01	1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE	2015-10-01
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526	NDA	NextWave Pharmaceuticals, Inc	24478-106-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)	2021-11-04
Tris Pharma Inc	DYANAVEL XR 15	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526	NDA	NextWave Pharmaceuticals, Inc	24478-106-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)	2021-11-04
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526	NDA	NextWave Pharmaceuticals, Inc	24478-106-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)	2021-11-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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