Application 207960

Type: NDA
Sponsor: NEXTWAVE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	20MG	Yes	No
002	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	30MG	Yes	No
003	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207960-001	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04
N207960-002	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04
N207960-003	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207960-001	8202537	2027-03-15		Drug product	2015-12-23
N207960-001	8287903	2031-02-15		Drug product	2015-12-23
N207960-001	10857143	2033-08-14	U-2993	Drug product	2020-12-08
N207960-001	11103494	2033-08-14		Drug product	2021-08-31
N207960-001	11103495	2033-08-14	U-2993	Drug product	2021-08-31
N207960-001	11633389	2033-08-14		Drug product	2023-05-09
N207960-001	8999386	2033-08-14		Drug product	2015-12-23
N207960-001	9295642	2033-08-14	U-1827	Drug product	2016-04-01
N207960-001	9545399	2033-08-14	U-1827	Drug product	2017-01-30
N207960-001	9844544	2033-08-14	U-2203	Drug product	2017-12-21
N207960-002	8202537	2027-03-15		Drug product	2015-12-23
N207960-002	8287903	2031-02-15		Drug product	2015-12-23
N207960-002	10857143	2033-08-14	U-2993	Drug product	2020-12-08
N207960-002	11103494	2033-08-14		Drug product	2021-08-31
N207960-002	11103495	2033-08-14	U-2993	Drug product	2021-08-31
N207960-002	11633389	2033-08-14		Drug product	2023-05-09
N207960-002	8999386	2033-08-14		Drug product	2015-12-23
N207960-002	9295642	2033-08-14	U-1827	Drug product	2016-04-01
N207960-002	9545399	2033-08-14	U-1827	Drug product	2017-01-30
N207960-002	9844544	2033-08-14	U-2203	Drug product	2017-12-21
N207960-003	8202537	2027-03-15		Drug product	2015-12-23
N207960-003	8287903	2031-02-15		Drug product	2015-12-23
N207960-003	10857143	2033-08-14	U-2993	Drug product	2020-12-08
N207960-003	11103494	2033-08-14		Drug product	2021-08-31
N207960-003	11103495	2033-08-14	U-2993	Drug product	2021-08-31
N207960-003	11633389	2033-08-14		Drug product	2023-05-09
N207960-003	8999386	2033-08-14		Drug product	2015-12-23
N207960-003	9295642	2033-08-14	U-1827	Drug product	2016-04-01
N207960-003	9545399	2033-08-14	U-1827	Drug product	2017-01-30
N207960-003	9844544	2033-08-14	U-2203	Drug product	2017-12-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,167 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207960-001	8202537	2027-03-15		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	8287903	2031-02-15		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	11103494	2033-08-14		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	11633389	2033-08-14		Drug product	2023-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	8999386	2033-08-14		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-001	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	8202537	2027-03-15		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	8287903	2031-02-15		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	11103494	2033-08-14		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	11633389	2033-08-14		Drug product	2023-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	8999386	2033-08-14		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-002	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	8202537	2027-03-15		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	8287903	2031-02-15		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	11103494	2033-08-14		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	11633389	2033-08-14		Drug product	2023-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	8999386	2033-08-14		Drug product	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207960-003	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207960-001	8202537	2027-03-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	8287903	2031-02-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	11103494	2033-08-14		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	11633389	2033-08-14		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	8999386	2033-08-14		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`caaa826d4ba7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	e817377f-bc72-415a-acd2-7136746b2479	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b77128b3-fce4-4bee-bdad-5fe4af9d612d	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c87a2000-b75c-41df-8497-7e00a9b41ad4	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	371346d1-ac7e-491c-a010-ad29cb3d567a	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ec3d9304-13bc-4f0b-bf14-1a1ea824bd91	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	b1b0f2ff-d9df-42ab-b471-226ecf97e075	2024-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	8e97c9f3-956c-416a-a7c2-68bb92053ce5	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Accord Healthcare, Inc.	4f3c91e6-4576-4326-bdab-7d8fb7c09bb8	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	11f4ec97-ed86-48b5-af3a-446b882294cb	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	1da9dc9e-7e8e-457a-93d4-9c2aee434e69	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b9c31526-d486-433c-9b3c-7a12765afe94	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ad3a3865-952e-46cf-8387-1228e2375312	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ea5a6d4e-60ba-46f3-b314-3c7a970b377d	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	ec8a8896-077d-4dee-9e10-97172512c5ed	2024-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	4cc16009-44ad-4055-ac76-efa282f1ff47	2024-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	7293dffd-eb01-43d4-b9c4-04f79bec180c	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	213ca0da-dde8-48ee-ac8c-c66558e6f62d	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b49863bd-20ba-44d5-8dab-96fcbd276a5c	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24478-074	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-074	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-075	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-075	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-076	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-076	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-120	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc.	NDA	Current
24478-130	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc.	NDA	Current
24478-140	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85340	SUPPL	2026-03-12
85339	SUPPL	2026-03-12
83594	SUPPL	2025-09-30
83485	SUPPL	2025-09-25
83483	SUPPL	2025-09-25
75889	SUPPL	2023-10-23
75759	SUPPL	2023-10-16
67940	SUPPL	2021-06-29
67936	SUPPL	2021-06-29
67935	SUPPL	2021-06-29
47496	SUPPL	2017-03-08
47494	SUPPL	2017-03-08
47459	SUPPL	2017-03-03
46843	SUPPL	2017-01-17
46711	SUPPL	2017-01-06
23046	ORIG	2016-07-19
40604	ORIG	2015-12-08
32871	ORIG	2015-12-08
51366	ORIG	1900-01-01
51365	ORIG	1900-01-01
51364	ORIG	1900-01-01
51363	ORIG	1900-01-01