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 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
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 · 105 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	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 522 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	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	9603853	2033-02-07	U-727		2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	9662338	2035-04-02		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	11324753	2029-09-04	U-727		2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	11458143	2029-09-04	U-727		2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	12121523	2029-09-04	U-727		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	9358204	2033-02-07		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	9603853	2033-02-07	U-727		2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	9662338	2035-04-02		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	11324753	2029-09-04	U-727		2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	11458143	2029-09-04	U-727		2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	12121523	2029-09-04	U-727		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	9358204	2033-02-07		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	9603853	2033-02-07	U-727		2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	9662338	2035-04-02		Drug product	2021-04-29	`84e616aacf4f…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 186 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N211964-001	NCE	2026-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	NCE	2026-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	NCE	2026-04-02	`84e616aacf4f…`
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…`

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 · 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