Application 208082

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUSTEDO	DEUTETRABENAZINE	TABLET;ORAL	6MG	Yes	No
002	AUSTEDO	DEUTETRABENAZINE	TABLET;ORAL	9MG	Yes	No
003	AUSTEDO	DEUTETRABENAZINE	TABLET;ORAL	12MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208082-001	AUSTEDO	DEUTETRABENAZINE	6MG	TABLET / ORAL	RLD	2017-04-03
N208082-002	AUSTEDO	DEUTETRABENAZINE	9MG	TABLET / ORAL	RLD	2017-04-03
N208082-003	AUSTEDO	DEUTETRABENAZINE	12MG	TABLET / ORAL	RLD, RS	2017-04-03

Orange Book patents#

Current patent rows page 1 of 2 · 96 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208082-001	8524733	2031-04-03		Drug substance, Drug product	2017-04-04
N208082-001	8524733*PED	2031-10-03		Pediatric extension
N208082-001	11666566	2033-09-18		Drug product	2023-06-16
N208082-001	9233959	2033-09-18		Drug product	2017-04-04
N208082-001	9296739	2033-09-18		Drug product	2017-04-04
N208082-001	9550780	2033-09-18	U-1995	Drug substance, Drug product	2017-04-04
N208082-001	9550780	2033-09-18	U-3055	Drug substance, Drug product	2017-04-04
N208082-001	9814708	2033-09-18		Drug product	2017-11-16
N208082-001	11666566*PED	2034-03-18		Pediatric extension
N208082-001	9233959*PED	2034-03-18		Pediatric extension
N208082-001	9296739*PED	2034-03-18		Pediatric extension
N208082-001	9550780*PED	2034-03-18		Pediatric extension
N208082-001	9814708*PED	2034-03-18		Pediatric extension
N208082-001	10959996	2036-03-07	U-3055		2021-03-31
N208082-001	11357772	2036-03-07	U-1995		2022-06-27
N208082-001	11357772	2036-03-07	U-3055		2022-06-27
N208082-001	11446291	2036-03-07	U-1995		2022-10-13
N208082-001	11564917	2036-03-07	U-1995		2023-02-15
N208082-001	11648244	2036-03-07	U-1995		2023-06-05
N208082-001	12016858	2036-03-07	U-1995		2024-07-25
N208082-001	12016858	2036-03-07	U-3055		2024-07-25
N208082-001	10959996*PED	2036-09-07		Pediatric extension
N208082-001	11357772*PED	2036-09-07		Pediatric extension
N208082-001	11446291*PED	2036-09-07		Pediatric extension
N208082-001	11564917*PED	2036-09-07		Pediatric extension
N208082-001	11648244*PED	2036-09-07		Pediatric extension
N208082-001	12016858*PED	2036-09-07		Pediatric extension
N208082-001	11179386	2038-03-15	U-1995	Drug product	2021-12-02
N208082-001	11179386	2038-03-15	U-3055	Drug product	2021-12-02
N208082-001	11813232	2038-03-15		Drug product	2023-12-07
N208082-001	11179386*PED	2038-09-15		Pediatric extension
N208082-001	11813232*PED	2038-09-15		Pediatric extension
N208082-002	8524733	2031-04-03		Drug substance, Drug product	2017-04-04
N208082-002	8524733*PED	2031-10-03		Pediatric extension
N208082-002	11666566	2033-09-18		Drug product	2023-06-16
N208082-002	9233959	2033-09-18		Drug product	2017-04-04
N208082-002	9296739	2033-09-18		Drug product	2017-04-04
N208082-002	9550780	2033-09-18	U-1995	Drug substance, Drug product	2017-04-04
N208082-002	9550780	2033-09-18	U-3055	Drug substance, Drug product	2017-04-04
N208082-002	9814708	2033-09-18		Drug product	2017-11-16
N208082-002	11666566*PED	2034-03-18		Pediatric extension
N208082-002	9233959*PED	2034-03-18		Pediatric extension
N208082-002	9296739*PED	2034-03-18		Pediatric extension
N208082-002	9550780*PED	2034-03-18		Pediatric extension
N208082-002	9814708*PED	2034-03-18		Pediatric extension
N208082-002	10959996	2036-03-07	U-3055		2021-03-31
N208082-002	11357772	2036-03-07	U-1995		2022-06-27
N208082-002	11357772	2036-03-07	U-3055		2022-06-27
N208082-002	11446291	2036-03-07	U-1995		2022-10-13
N208082-002	11564917	2036-03-07	U-1995		2023-02-15
N208082-002	11648244	2036-03-07	U-1995		2023-06-05
N208082-002	12016858	2036-03-07	U-1995		2024-07-25
N208082-002	12016858	2036-03-07	U-3055		2024-07-25
N208082-002	10959996*PED	2036-09-07		Pediatric extension
N208082-002	11357772*PED	2036-09-07		Pediatric extension
N208082-002	11446291*PED	2036-09-07		Pediatric extension
N208082-002	11564917*PED	2036-09-07		Pediatric extension
N208082-002	11648244*PED	2036-09-07		Pediatric extension
N208082-002	12016858*PED	2036-09-07		Pediatric extension
N208082-002	11179386	2038-03-15	U-1995	Drug product	2021-12-02
N208082-002	11179386	2038-03-15	U-3055	Drug product	2021-12-02
N208082-002	11813232	2038-03-15		Drug product	2023-12-07
N208082-002	11179386*PED	2038-09-15		Pediatric extension
N208082-002	11813232*PED	2038-09-15		Pediatric extension
N208082-003	8524733	2031-04-03		Drug substance, Drug product	2017-04-04
N208082-003	8524733*PED	2031-10-03		Pediatric extension
N208082-003	11666566	2033-09-18		Drug product	2023-06-16
N208082-003	9233959	2033-09-18		Drug product	2017-04-04
N208082-003	9296739	2033-09-18		Drug product	2017-04-04
N208082-003	9550780	2033-09-18	U-1995	Drug substance, Drug product	2017-04-04
N208082-003	9550780	2033-09-18	U-3055	Drug substance, Drug product	2017-04-04
N208082-003	9814708	2033-09-18		Drug product	2017-11-16
N208082-003	11666566*PED	2034-03-18		Pediatric extension
N208082-003	9233959*PED	2034-03-18		Pediatric extension
N208082-003	9296739*PED	2034-03-18		Pediatric extension
N208082-003	9550780*PED	2034-03-18		Pediatric extension
N208082-003	9814708*PED	2034-03-18		Pediatric extension
N208082-003	10959996	2036-03-07	U-3055		2021-03-31
N208082-003	11357772	2036-03-07	U-1995		2022-06-27
N208082-003	11357772	2036-03-07	U-3055		2022-06-27

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-001	AUSTEDO	6MG	TABLET / ORAL	AB	RLD	2017-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-002	AUSTEDO	9MG	TABLET / ORAL	AB	RLD	2017-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-003	AUSTEDO	12MG	TABLET / ORAL	AB	RLD, RS	2017-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208082-002	AUSTEDO	9MG	TABLET / ORAL		RLD	2017-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208082-003	AUSTEDO	12MG	TABLET / ORAL		RLD, RS	2017-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208082-001	AUSTEDO	6MG	TABLET / ORAL		RLD	2017-04-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-003	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 68 · 2,706 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208082-001	8524733	2031-04-03		Drug substance, Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	8524733*PED	2031-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11666566	2033-09-18		Drug product	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9233959	2033-09-18		Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9296739	2033-09-18		Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9550780	2033-09-18	U-1995	Drug substance, Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9550780	2033-09-18	U-3055	Drug substance, Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9814708	2033-09-18		Drug product	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11666566*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9233959*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9296739*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9550780*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	9814708*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	10959996	2036-03-07	U-3055		2021-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11357772	2036-03-07	U-1995		2022-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11357772	2036-03-07	U-3055		2022-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11446291	2036-03-07	U-1995		2022-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11564917	2036-03-07	U-1995		2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11648244	2036-03-07	U-1995		2023-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	12016858	2036-03-07	U-1995		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	12016858	2036-03-07	U-3055		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	10959996*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11357772*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11446291*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11564917*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11648244*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	12016858*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11179386	2038-03-15	U-1995	Drug product	2021-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11179386	2038-03-15	U-3055	Drug product	2021-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11813232	2038-03-15		Drug product	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11179386*PED	2038-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-001	11813232*PED	2038-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	8524733	2031-04-03		Drug substance, Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	8524733*PED	2031-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	11666566	2033-09-18		Drug product	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	9233959	2033-09-18		Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	9296739	2033-09-18		Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	9550780	2033-09-18	U-1995	Drug substance, Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	9550780	2033-09-18	U-3055	Drug substance, Drug product	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208082-002	9814708	2033-09-18		Drug product	2017-11-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 450 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-001	ODE-134	2024-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-001	M-54	2024-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-001	PED	2024-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-001	PED	2024-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-002	ODE-134	2024-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-002	M-54	2024-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-002	PED	2024-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-002	PED	2024-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-003	ODE-134	2024-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-003	M-54	2024-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-003	PED	2024-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208082-003	PED	2024-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-001	ODE-134	2024-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-001	M-54	2024-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-001	PED	2024-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-001	PED	2024-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-002	ODE-134	2024-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-002	M-54	2024-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-002	PED	2024-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-002	PED	2024-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-003	ODE-134	2024-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-003	M-54	2024-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-003	PED	2024-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208082-003	PED	2024-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-001	ODE-134	2024-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-001	M-54	2024-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-001	PED	2024-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-001	PED	2024-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-002	ODE-134	2024-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-002	M-54	2024-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-002	PED	2024-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-002	PED	2024-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-003	ODE-134	2024-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-003	M-54	2024-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-003	PED	2024-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208082-003	PED	2024-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-001	ODE-134	2024-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-001	M-54	2024-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-001	PED	2024-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208082-001	PED	2024-12-24	`d8e5a09893c0…`

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
Austedo	DEUTETRABENAZINE	Teva Neuroscience, Inc.	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208082 application number: NDA208082 ndc (product): 68546-177 ndc (product): 68546-172 ndc (product): 68546-182 ndc (product): 68546-171 ndc (product): 68546-170 ndc (product): 68546-181 ndc (product): 68546-176

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-170	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-171	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-172	Austedo	Deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-176	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-177	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-181	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-181	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-181	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-181	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-181	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-182	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-182	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-182	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-182	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current
68546-182	AUSTEDO	deutetrabenazine	Teva Neuroscience, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82374	SUPPL	2025-06-02
81409	SUPPL	2025-03-03
81408	SUPPL	2025-03-03
80470	SUPPL	2024-12-02
80469	SUPPL	2024-12-02
80441	SUPPL	2024-11-29
80440	SUPPL	2024-11-29
75624	SUPPL	2023-09-29
75616	SUPPL	2023-09-29
71020	SUPPL	2022-05-06
71019	SUPPL	2022-05-06
72250	SUPPL	2022-05-05
71000	SUPPL	2022-05-05
67922	SUPPL	2021-06-28
67920	SUPPL	2021-06-28
67902	SUPPL	2021-06-25
67532	SUPPL	2021-05-18
66164	SUPPL	2021-02-09
65494	SUPPL	2020-12-03
65480	SUPPL	2020-12-02
65479	SUPPL	2020-12-02
59351	SUPPL	2019-07-16
59350	SUPPL	2019-07-16
59341	SUPPL	2019-07-16
54553	SUPPL	2018-06-14
54488	SUPPL	2018-06-08
48378	ORIG	2017-05-15
47845	ORIG	2017-04-03
47844	ORIG	2017-04-03