Application 202100

Type: NDA
Sponsor: NEXTWAVE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUILLIVANT XR	METHYLPHENIDATE HYDROCHLORIDE	FOR SUSPENSION, EXTENDED RELEASE;ORAL	5MG/ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24478-190	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-200	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-205	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-210	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-321	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-321	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-321	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-321	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-322	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-322	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-322	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-322	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-323	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-323	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-323	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-323	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-324	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-324	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-324	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-324	Quillivant	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85319	SUPPL	2026-03-10
85318	SUPPL	2026-03-10
83593	SUPPL	2025-09-30
83592	SUPPL	2025-09-30
83484	SUPPL	2025-09-25
83482	SUPPL	2025-09-25
75888	SUPPL	2023-10-23
75760	SUPPL	2023-10-16
67939	SUPPL	2021-06-29
67934	SUPPL	2021-06-29
67933	SUPPL	2021-06-29
47000	SUPPL	2017-01-27
46978	SUPPL	2017-01-24
46842	SUPPL	2017-01-17
46841	SUPPL	2017-01-17
46710	SUPPL	2017-01-06
40119	SUPPL	2016-05-17
32178	SUPPL	2016-05-16
19059	SUPPL	2015-07-22
32177	SUPPL	2015-07-14
40118	SUPPL	2015-04-21
32176	SUPPL	2015-04-20
23956	ORIG	2013-12-27
40117	SUPPL	2013-12-17
9959	SUPPL	2013-12-13
40116	SUPPL	2013-08-12
9958	SUPPL	2013-08-12
43383	ORIG	2013-07-08
24407	ORIG	2013-07-08
19058	SUPPL	2013-05-21
32175	ORIG	2012-10-02
40115	ORIG	2012-09-28
63528	ORIG	1900-01-01
63527	ORIG	1900-01-01
51362	ORIG	1900-01-01
51361	ORIG	1900-01-01
51360	ORIG	1900-01-01

Application 202100

Related Records#

Application Products#

NDC Listings For This Application#

Documents#