Application 211964

Type: NDA
Sponsor: SUPERNUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QELBREE	VILOXAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No
002	QELBREE	VILOXAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	Yes	No
003	QELBREE	VILOXAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N211964-001	QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02
N211964-002	QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02
N211964-003	QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211964-001	11324753	2029-09-04	U-727		2022-05-17
N211964-001	11458143	2029-09-04	U-727		2022-10-07
N211964-001	12121523	2029-09-04	U-727		2024-11-21
N211964-001	9358204	2033-02-07		Drug product	2021-04-29
N211964-001	9603853	2033-02-07	U-727		2021-04-29
N211964-001	9662338	2035-04-02		Drug product	2021-04-29
N211964-002	11324753	2029-09-04	U-727		2022-05-17
N211964-002	11458143	2029-09-04	U-727		2022-10-07
N211964-002	12121523	2029-09-04	U-727		2024-11-21
N211964-002	9358204	2033-02-07		Drug product	2021-04-29
N211964-002	9603853	2033-02-07	U-727		2021-04-29
N211964-002	9662338	2035-04-02		Drug product	2021-04-29
N211964-003	11324753	2029-09-04	U-727		2022-05-17
N211964-003	11458143	2029-09-04	U-727		2022-10-07
N211964-003	12121523	2029-09-04	U-727		2024-11-21
N211964-003	9358204	2033-02-07		Drug product	2021-04-29
N211964-003	9603853	2033-02-07	U-727		2021-04-29
N211964-003	9662338	2035-04-02		Drug product	2021-04-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211964-001	NCE	2026-04-02
N211964-002	NCE	2026-04-02
N211964-003	NCE	2026-04-02

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 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 504 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	9603853	2033-02-07	U-727		2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	9662338	2035-04-02		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	11324753	2029-09-04	U-727		2022-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	11458143	2029-09-04	U-727		2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	12121523	2029-09-04	U-727		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	9358204	2033-02-07		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	9603853	2033-02-07	U-727		2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	9662338	2035-04-02		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	11324753	2029-09-04	U-727		2022-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	11458143	2029-09-04	U-727		2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	12121523	2029-09-04	U-727		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	9358204	2033-02-07		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	9603853	2033-02-07	U-727		2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	9662338	2035-04-02		Drug product	2021-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	9603853	2033-02-07	U-727		2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	9662338	2035-04-02		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	11324753	2029-09-04	U-727		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	11458143	2029-09-04	U-727		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	12121523	2029-09-04	U-727		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	9358204	2033-02-07		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	9603853	2033-02-07	U-727		2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	9662338	2035-04-02		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	11324753	2029-09-04	U-727		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	11458143	2029-09-04	U-727		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	12121523	2029-09-04	U-727		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	9358204	2033-02-07		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	9603853	2033-02-07	U-727		2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	9662338	2035-04-02		Drug product	2021-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 183 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211964-001	NCE	2026-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	NCE	2026-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	NCE	2026-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211964-001	NCE	2026-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	NCE	2026-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	NCE	2026-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	NPP	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	NCE	2026-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-002	NPP	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-002	NCE	2026-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-003	NPP	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-003	NCE	2026-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211964-001	NPP	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-001	NCE	2026-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-002	NPP	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-002	NCE	2026-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-003	NPP	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-003	NCE	2026-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-001	NPP	2025-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-001	NCE	2026-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-002	NPP	2025-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-002	NCE	2026-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-003	NPP	2025-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-003	NCE	2026-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-001	NPP	2025-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-001	NCE	2026-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-002	NPP	2025-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-002	NCE	2026-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-003	NPP	2025-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-003	NCE	2026-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-001	NPP	2025-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-001	NCE	2026-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-002	NPP	2025-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-002	NCE	2026-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-003	NPP	2025-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-003	NCE	2026-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-001	NPP	2025-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-001	NCE	2026-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-002	NPP	2025-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-002	NCE	2026-04-02	`2680178bc6a6…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QELBREE	VILOXAZINE HYDROCHLORIDE	Supernus Pharmaceuticals, Inc	aedf408d-0f84-418d-9416-7c39ddb0d29a	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211964 application number: NDA211964 ndc (product): 17772-133 ndc (product): 17772-132 ndc (product): 17772-131

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81094	SUPPL	2025-02-06
81093	SUPPL	2025-02-06
81040	SUPPL	2025-02-06
81039	SUPPL	2025-02-06
70955	SUPPL	2022-05-03
70872	SUPPL	2022-05-02
70871	SUPPL	2022-05-02
68096	ORIG	2021-05-03
67320	ORIG	2021-05-03
66992	ORIG	2021-04-06
67616	ORIG	2021-04-05
66988	ORIG	2021-04-02
66987	ORIG	2021-04-02