Application 078101

Type: ANDA
Sponsor: TEVA 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 43.

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	Approval date
A078101-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15
A078101-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15
A078101-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15
A078101-004	LEVETIRACETAM	LEVETIRACETAM	1GM	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078101-001	LEVETIRACETAM	250MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078101-002	LEVETIRACETAM	500MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078101-003	LEVETIRACETAM	750MG	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078101-004	LEVETIRACETAM	1GM	TABLET / ORAL	2009-01-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078101-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078101-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078101-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078101-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078101-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078101-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078101-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078101-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078101-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078101-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078101-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078101-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078101-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078101-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078101-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078101-004	AB	1	`ea99ee380514…`

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 5 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	18648f51-a37c-41e1-b451-123bc0cf5446	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	671a1ae1-f672-48da-8a69-94c147472003	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Spritam	LEVETIRACETAM	Aprecia Pharmaceuticals, LLC	be651c31-383f-11e4-916c-0800200c9a66	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	792db8dc-177b-4864-8600-12823819082d	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Quallent Pharmaceuticals Health LLC	3756f052-919c-4817-a56e-1091fd514d9d	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	NorthStar RxLLC	3884cb76-822b-400d-9b24-49c286c9b6f7	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	SOHM, Inc.	0a688786-879b-4e27-a46a-5c86bbfa1292	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	c4b27429-50a3-467c-a5ff-7e49a01a1088	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Precision Dose, Inc.	6fb1e4d3-520c-44f1-a09d-d7b779e4edfd	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Rising Pharma Holdings, Inc.	db423b93-d7c2-4cf2-829b-24b657f27f93	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	e31c6830-4647-4481-b4f1-494a52c48b1b	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Prasco Laboratories	dd175fa3-1d7a-4542-affd-988ac5bba1db	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Keppra	LEVETIRACETAM	UCB, Inc.	c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Keppra XR	LEVETIRACETAM	UCB, Inc.	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM IN SODIUM CHLORIDE	Caplin Steriles Limited	563171fb-df26-4f95-853a-fd7707da291c	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
Levetiracetam	LEVETIRACETAM	OWP Pharmaceuticals, Inc.	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hikma Pharmaceuticals USA Inc.	097e5606-dd5e-4518-ab97-f71f68786444	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Civica, Inc.	1591c690-f4ed-44b7-a9d0-bff1fbb4bfef	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Mylan Pharmaceuticals Inc.	0a987d59-560f-4650-96ec-31aec81953b5	2025-04-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	QUAGEN PHARMACEUTICALS LLC	1d67cb3c-1173-4dce-a79b-a3c36934ab2e	2025-04-03	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.