Application 217878

Type: ANDA
Sponsor: GRANULES

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 45.

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
A217878-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13
A217878-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13
A217878-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13
A217878-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13

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 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217878-001	LEVETIRACETAM	250MG	TABLET / ORAL	2023-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217878-002	LEVETIRACETAM	500MG	TABLET / ORAL	2023-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217878-003	LEVETIRACETAM	750MG	TABLET / ORAL	2023-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217878-004	LEVETIRACETAM	1GM	TABLET / ORAL	2023-06-13	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217878-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217878-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217878-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217878-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217878-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217878-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217878-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217878-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217878-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217878-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217878-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217878-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217878-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217878-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217878-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217878-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217878-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217878-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217878-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217878-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217878-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217878-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217878-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217878-004	AB	1	`a67488948f0b…`

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 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	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	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
Levetiracetam	LEVETIRACETAM	Hikma Pharmaceuticals USA Inc.	8d767545-1eb9-45a5-bd16-e8a66e628fea	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Solco Healthcare US, LLC	cfe618ae-f7de-43d8-a754-3ce0a08c48ee	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals Inc.	8c16bc7b-672c-420a-a457-350060533375	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	c82313cb-744f-45ef-b74c-1bdd055b2193	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Kesin Pharma Corporation	30a4626d-74f3-6385-e063-6394a90a2950	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c2177034-e164-453c-be02-1cf91ce27a07	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	American Health Packaging	3be7c30b-f35d-4dde-8bf8-24f67bd70865	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	2d596153-c49b-273f-e063-6294a90ac663	2025-02-04	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.