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 7 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	adbcb0f7-0421-47e2-854e-e1cfefb6386f	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	Mylan Institutional LLC	e86dc508-4d22-493b-bdf1-408b6484d3f1	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Hospira, Inc.	ed1b74a8-2a9b-4315-b051-673c7941cb13	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	Baxter Healthcare Corporation	3d88adda-9580-44bf-b75c-d615c973c1e1	2024-05-06	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
Levetiracetam in Sodium Chloride	LEVETIRACETAM	Nexus Pharmaceuticals LLC	ee014183-a857-457b-9573-0cc168e560f3	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Camber Pharmaceuticals, Inc.	63b36274-89f0-42d8-9f09-f9e78e179af4	2024-04-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	B. Braun Medical Inc.	ad32ec2f-b4e0-4811-8ea1-7a4abdd5c0a6	2024-04-23	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	Sagent Pharmaceuticals	d2de9565-0c0b-4957-bafa-1a286103709e	2024-04-18	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Aurobindo Pharma Limited	2471ee03-d747-4113-86d0-1aa93c8f3eba	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Novadoz Pharmaceuticals LLC	484e8d8f-be40-46f8-a509-d1bbdbbd2981	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	ed8e88d0-993e-4683-bdcf-31578130d3df	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM IN SODIUM CHLORIDE	Eugia US LLC	e5eb4c89-8ee9-4474-9cb1-c3b3dc262a4a	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
LEVETIRACETAM	LEVETIRACETAM	Solco healthcare U.S., LLC	bc8644ed-3320-47b5-adf3-8b972bea8abd	2024-03-28	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Solco Healthcare US, LLC	57f09129-7151-4a75-9d73-9dd32f74ba43	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Solco Healthcare US, LLC	dd713e60-478c-43cd-b680-ff594a0b3864	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PAI Holdings, LLC dba PAI Pharma	9dca1330-52ca-47a4-a134-ec55c9d5786d	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
ELEPSIA XR 1000 MG	LEVETIRACETAM	TRIPOINT THERAPEUTICS, LLC	cac83d47-88a2-4447-a0c0-90b44ffda0ac	2024-03-25	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Gland Pharma Limited	aa883d9c-c6cd-44ab-a1de-058985e4f97f	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Mylan Institutional LLC	70e52e89-3844-4cd9-a406-b29e9520a12c	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Proficient Rx LP	6bdbc193-d86b-4bd5-8e88-4ea964d2cdde	2024-03-01	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.