Home Applications 208082 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 44 .
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 TE codes 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 · 132 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 2026-10-15 13:18:30 2026-09 N208082-001 AUSTEDO 6MG TABLET / ORAL RLD 2017-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 AUSTEDO 9MG TABLET / ORAL RLD 2017-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-003 AUSTEDO 12MG TABLET / ORAL RLD, RS 2017-04-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208082-001 AUSTEDO 6MG TABLET / ORAL RLD 2017-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208082-002 AUSTEDO 9MG TABLET / ORAL RLD 2017-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208082-003 AUSTEDO 12MG TABLET / ORAL RLD, RS 2017-04-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208082-001 AUSTEDO 6MG TABLET / ORAL RLD 2017-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208082-002 AUSTEDO 9MG TABLET / ORAL RLD 2017-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208082-003 AUSTEDO 12MG TABLET / ORAL RLD, RS 2017-04-03 caaa826d4ba7…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…
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 75 · 2,994 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N208082-001 8524733 2031-04-03 Drug substance, Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 8524733*PED 2031-10-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11666566 2033-09-18 Drug product 2023-06-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9233959 2033-09-18 Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9296739 2033-09-18 Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9550780 2033-09-18 U-1995 Drug substance, Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9550780 2033-09-18 U-3055 Drug substance, Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9814708 2033-09-18 Drug product 2017-11-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11666566*PED 2034-03-18 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9233959*PED 2034-03-18 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9296739*PED 2034-03-18 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9550780*PED 2034-03-18 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 9814708*PED 2034-03-18 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 10959996 2036-03-07 U-3055 2021-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11357772 2036-03-07 U-1995 2022-06-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11357772 2036-03-07 U-3055 2022-06-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11446291 2036-03-07 U-1995 2022-10-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11564917 2036-03-07 U-1995 2023-02-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11648244 2036-03-07 U-1995 2023-06-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 12016858 2036-03-07 U-1995 2024-07-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 12016858 2036-03-07 U-3055 2024-07-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 10959996*PED 2036-09-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11357772*PED 2036-09-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11446291*PED 2036-09-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11564917*PED 2036-09-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11648244*PED 2036-09-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 12016858*PED 2036-09-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11179386 2038-03-15 U-1995 Drug product 2021-12-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11179386 2038-03-15 U-3055 Drug product 2021-12-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11813232 2038-03-15 Drug product 2023-12-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11179386*PED 2038-09-15 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-001 11813232*PED 2038-09-15 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 8524733 2031-04-03 Drug substance, Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 8524733*PED 2031-10-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 11666566 2033-09-18 Drug product 2023-06-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 9233959 2033-09-18 Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 9296739 2033-09-18 Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 9550780 2033-09-18 U-1995 Drug substance, Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 9550780 2033-09-18 U-3055 Drug substance, Drug product 2017-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208082-002 9814708 2033-09-18 Drug product 2017-11-16 c2088c7a36db…
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…
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 · 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