Application 209739

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TETRABENAZINE	TETRABENAZINE	TABLET;ORAL	12.5MG	No	No
002	TETRABENAZINE	TETRABENAZINE	TABLET;ORAL	25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209739-001	TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET / ORAL			2019-04-08
A209739-002	TETRABENAZINE	TETRABENAZINE	25MG	TABLET / ORAL			2019-04-08

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2019-04-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL		2019-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2019-04-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2019-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2019-04-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2019-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209739-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2019-04-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209739-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2019-04-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209739-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209739-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209739-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209739-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209739-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209739-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209739-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209739-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209739-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209739-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209739-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209739-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209739-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209739-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209739-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209739-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209739-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209739-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209739-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209739-002	AB	1	`ea99ee380514…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetrabenazine	TETRABENAZINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	5042f30c-c922-4835-bf6d-40905f2dc76c	2026-07-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Golden State Medical Supply, Inc.	cbfb791e-26ac-9fb5-e053-2995a90ac7e5	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Apotex Corp.	471ac1d8-e3ad-7729-87c5-c26ae92c32eb	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
TETRABENAZINE	TETRABENAZINE	Bionpharma Inc.	acf78d97-fca5-49aa-8683-6db7396da72f	2024-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TETRABENAZINE generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Sun Pharmaceutical Industries, Inc.	b7d93006-7f06-4da4-985e-6b948c2468e8	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Precision Dose Inc.	aca55884-1eb4-4a76-8c7f-96c782849337	2023-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Ajanta Pharma USA Inc.	6775241b-9703-4876-88fd-bbeb906f789d	2021-11-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
tetrabenazine	TETRABENAZINE	Slate Run Pharmaceuticals, LLC	49587379-1cc0-48ff-9f2f-517079cf499d	2020-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tetrabenazine generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Dr. Reddys Laboratories Inc	ef5f9dd4-945f-ec27-518d-90996a7bd4b6	2020-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE
tetrabenazine	TETRABENAZINE	Oceanside Pharmaceuticals	5867189c-17bd-4e70-a079-c4730f9950d1	2019-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tetrabenazine generic name: TETRABENAZINE
Xenazine	TETRABENAZINE	Lundbeck Pharmaceuticals LLC	ac768bab-8afa-4446-bc7f-caeeffec0cda	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TETRABENAZINE
Tetrabenazine	TETRABENAZINE	Camber Pharmaceuticals, Inc.	a03c3cf8-fcd4-4dbf-a4f5-59bd7887c902	2018-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tetrabenazine generic name: TETRABENAZINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0468	Tetrabenazine	Tetrabenazine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0468	Tetrabenazine	Tetrabenazine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0469	Tetrabenazine	Tetrabenazine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0469	Tetrabenazine	Tetrabenazine	Hikma Pharmaceuticals USA Inc.	ANDA	Current