Application 090767

Type: ANDA
Sponsor: ACIC 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
004	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	1GM	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090767-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28
A090767-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28
A090767-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28
A090767-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090767-001	AB
A090767-002	AB
A090767-003	AB
A090767-004	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 5 · 164 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	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090767-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090767-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090767-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090767-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-07-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090767-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090767-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090767-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090767-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090767-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090767-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090767-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090767-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090767-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090767-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090767-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090767-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090767-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090767-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090767-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090767-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090767-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090767-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090767-004	AB	1	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	671a1ae1-f672-48da-8a69-94c147472003	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090767 application number: ANDA090767
Levetiracetam	LEVETIRACETAM	Rising Pharma Holdings, Inc.	db423b93-d7c2-4cf2-829b-24b657f27f93	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090767 application number: ANDA090767
Levetiracetam	LEVETIRACETAM	Amneal Pharmaceuticals LLC	d7932a2c-a3b7-46df-a306-1f17716160a0	2017-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090767 application number: ANDA090767 ndc (product): 65162-538 ndc (product): 65162-528 ndc (product): 65162-539 ndc (product): 65162-529

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-954	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-954	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-955	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-955	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-956	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-956	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-957	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
42385-957	Levetiracetam	Levetiracetam	Laurus Generics Inc.	ANDA	Current
50090-5495	Levetiracetam	Levetiracetam	A-S Medication Solutions	ANDA	Current
65162-528	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-528	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-528	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-528	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-529	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-529	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-529	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-529	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-538	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-538	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-538	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-538	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-539	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-539	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-539	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-539	Levetiracetam	Levetiracetam	Amneal Pharmaceuticals LLC	ANDA	Current
67850-011	Levetiracetam	Levetiracetam	Methapharm, Inc.	ANDA	Current
67850-012	Levetiracetam	Levetiracetam	Methapharm, Inc.	ANDA	Current
67850-013	Levetiracetam	Levetiracetam	Methapharm, Inc.	ANDA	Current
67850-014	Levetiracetam	Levetiracetam	Methapharm, Inc.	ANDA	Current
70518-3317	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
71930-062	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-062	Levetiracetam	Levetiracetam	EYWA Pharma Inc.	ANDA	Current
71930-062	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-063	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-063	Levetiracetam	Levetiracetam	EYWA Pharma Inc.	ANDA	Current
71930-063	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-064	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-064	Levetiracetam	Levetiracetam	EYWA Pharma Inc.	ANDA	Current
71930-064	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-065	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current
71930-065	Levetiracetam	Levetiracetam	EYWA Pharma Inc.	ANDA	Current
71930-065	Levetiracetam	Levetiracetam	Eywa Pharma Inc.	ANDA	Current