Application 212688

Type: ANDA
Sponsor: OVERSEAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET, EXTENDED RELEASE;ORAL	750MG	No	No
002	LEVETIRACETAM	LEVETIRACETAM	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212688-001	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-11
A212688-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-05-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212688-001	AB
A212688-002	AB

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 · 61 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
2026-08-18 06:07:40	2026-07	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212688-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212688-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212688-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212688-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212688-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212688-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212688-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212688-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212688-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212688-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212688-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212688-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212688-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212688-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212688-001	AB	1	`782e0a99824c…`
2020-12-22 03:56 UTC	2020-12	A212688-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212688-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212688-001	AB	1	`1c564ffb4f44…`

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
LEVETIRACETAM Extended-release	LEVETIRACETAM	Omnivium Pharmaceuticals LLC	1a31134d-6b63-4d14-8445-0ed132e6c88d	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212688 application number: ANDA212688 ndc (product): 81665-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55488-0519	LEVETIRACETAM	LEVETIRACETAM	Changzhou Pharmaceutical Factory	ANDA	Current
81665-100	LEVETIRACETAM	LEVETIRACETAM	Omnivium Pharmaceuticals LLC	ANDA	Current