Application 090461

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	SOLUTION;ORAL	100MG/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090461-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2010-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090461-001	AA

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 2 · 41 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	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090461-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2010-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090461-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090461-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090461-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090461-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090461-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090461-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090461-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090461-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090461-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090461-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090461-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090461-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090461-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090461-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090461-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090461-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090461-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090461-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090461-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090461-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090461-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090461-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090461-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090461-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090461-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090461-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090461-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090461-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090461-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090461-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090461-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090461-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090461-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090461-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090461-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090461-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090461-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090461-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090461-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090461-001	AA	1	`cb3db0bc1861…`

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 9 · 165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam Levetiracetam	LEVETIRACETAM	Atlantic Biologicals Corp.	56fed03f-38c3-4273-8fd7-522bc508bf36	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	a91defd2-486b-4995-ba4c-640525ab575d	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	dfc218c5-672a-420a-b59e-2e0b054e99ad	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	ae405796-1eca-4890-bcb2-e1b07654a24d	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Bryant Ranch Prepack	ace53552-d616-45e8-9f99-2f0041d0b430	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	266d4ead-fda2-f030-e063-6394a90a68e2	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	1c26c0ad-9d37-45c5-9091-849509f4fc01	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	90e01877-abcb-4697-a7ed-9afe5ee77050	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Unit Dose Solutions, Inc.	551626eb-3282-e439-e063-6294a90a8314	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Direct_Rx	5517b148-1eff-6421-e063-6394a90a9498	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Bryant Ranch Prepack	bb6e1c75-66eb-4d18-af70-9b51fb67c4d6	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a05bbfa4-c34f-4134-8207-db79e4c70445	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	23073db5-3fc4-4051-a22d-e49a63e42647	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	94d042f7-93b9-43bd-9ace-cfc61903b4d7	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	74ccc9f1-b957-4b1b-9464-1b5e3318c916	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c4b2da6a-ed50-4a54-90bd-32f76b178736	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	53843871-23e3-974e-e063-6394a90a8042	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	f924d55d-d7ec-4448-b54e-3a7eaf5a1cab	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	c12d8af3-39a8-4690-8d47-43dec70b7579	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Injecta Medcial LLC	52fa0eec-3dd9-59ca-e063-6394a90a9791	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM