Application 078234

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	250MG	No	No
002	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	500MG	No	No
003	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	750MG	No	No

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	Approval date
A078234-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15
A078234-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15
A078234-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078234-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078234-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078234-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078234-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078234-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078234-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078234-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078234-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078234-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078234-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078234-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078234-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078234-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078234-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078234-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078234-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078234-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078234-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078234-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078234-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078234-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078234-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078234-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078234-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078234-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078234-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078234-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078234-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078234-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078234-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078234-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078234-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078234-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078234-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078234-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078234-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078234-001	AB	1	`6a51e52b5d6a…`

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	LEVETIRACETAM	Exelan Pharmaceuticals, Inc.	28c0e61e-1af9-410a-9fa9-b71bf99a776b	2018-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078234 application number: ANDA078234 ndc (product): 76282-247 ndc (product): 76282-246 ndc (product): 76282-248

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
53808-0377	Levetiracetam	Levetiracetam	State of Florida DOH Central Pharmacy	ANDA	Current
76282-246	Levetiracetam	Levetiracetam	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-247	Levetiracetam	Levetiracetam	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-248	Levetiracetam	Levetiracetam	Exelan Pharmaceuticals, Inc.	ANDA	Current