Application 090025

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090025-001	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB		2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090025-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090025-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090025-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090025-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090025-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090025-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090025-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090025-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090025-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090025-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090025-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090025-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090025-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090025-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090025-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090025-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090025-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090025-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090025-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090025-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090025-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090025-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090025-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090025-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090025-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090025-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090025-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090025-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090025-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090025-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090025-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090025-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090025-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090025-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090025-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090025-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090025-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090025-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090025-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090025-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090025-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090025-001	AB	1	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	df661166-325d-4071-9bc1-f7bf992996d2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090025 application number: ANDA090025 ndc (product): 68180-115
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	02e237ff-a3e0-40fe-a3d0-9d8802855c71	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090025 application number: ANDA090025

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7979	Levetiracetam	Levetiracetam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
57297-115	Levetiracetam	Levetiracetam	LUPIN LIMITED	ANDA	Current
68001-115	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-115	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-115	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-1998	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-1998	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current