Application 078526

Type: ANDA
Sponsor: ORCHID HLTHCARE

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 43.

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	TE codes	Approval date
A078526-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078526-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078526-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078526-001	AB
A078526-002	AB
A078526-003	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 4 · 129 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	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078526-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078526-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078526-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078526-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078526-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078526-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078526-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078526-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078526-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078526-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078526-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078526-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078526-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078526-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078526-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078526-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078526-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078526-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078526-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078526-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078526-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078526-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078526-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078526-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078526-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078526-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078526-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078526-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078526-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078526-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078526-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078526-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078526-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078526-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078526-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078526-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078526-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078526-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078526-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078526-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078526-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078526-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078526-001	AB	1	`301d65b070ca…`

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 4 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Advanced Rx of Tennessee, LLC	45a07f44-078d-0513-e063-6394a90a1629	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Advanced Rx of Tennessee, LLC	45a03a43-04db-9138-e063-6394a90a12fa	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Granules Pharmaceuticals Inc.	b4781ec4-43ad-4052-9a6a-b24fda119b32	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Guardian Drug Company	e77162ff-0ff9-45ca-95fc-da6ea24ce5a2	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam Extended-Release	LEVETIRACETAM	Golden State Medical Supply, Inc.	5dde1889-a217-4493-9a71-9fd39ed04630	2025-11-24	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	6e31e766-6504-4f20-8831-1953363cace0	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hp Halden Pharma AS	1d9abcce-8ef7-422b-bf4b-5835bf4dbb34	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hp Halden Pharma AS	6951de41-4a16-4cca-8039-44fc81407081	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hp Halden Pharma AS	35bb1e5f-d5cd-4e7f-a056-48c0cf9ebd76	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	01aef7f7-6092-4e39-8451-dc02d8db9254	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Baxter Healthcare Corporation	8e381590-1147-46f3-9cbd-dc9716013444	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	58ed7049-44c6-4f97-9174-c0e1504586a6	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	5eb7bea5-c95f-4a38-a5bb-c20d1549c797	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	43df4156-0958-e496-e063-6294a90a5329	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	b9597cd5-5745-494a-bd72-93071ed221da	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Mylan Institutional Inc.	08e1bfea-7f3f-42d9-823d-f75080e664ff	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM solution	LEVETIRACETAM	Chartwell Governmental & Specialty RX, LLC.	e1ebd960-79a4-4632-b727-4e9811824113	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Eugia US LLC	3e43c17f-7e7e-4ccd-b321-1dd5e62cdafd	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	TAGI Pharma, Inc.	72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-190	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42043-191	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42043-192	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42254-056	Levetiracetam	Levetiracetam	Rebel Distributors Corp	ANDA	Current