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 3 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	24f815ef-58e6-42b9-8137-adcd6c382aa6	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Torrent Pharmaceuticals Limited	7cb669d7-d1aa-43b3-a322-0a2eaa13c656	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	9e3171c9-70e2-4725-8aca-c7f83773940d	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	402b488c-1733-4bf7-a7a8-b60805b022c9	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Sun Pharmaceutical Industries, Inc.	bf412e94-ca36-4da9-83d7-fb0f1323cf21	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	02e237ff-a3e0-40fe-a3d0-9d8802855c71	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM solution	LEVETIRACETAM	Chartwell RX, LLC	61eb57a9-5df2-4426-9f0c-a75e2f356b11	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	DIRECT RX	c3b62114-a590-f4db-e053-2995a90a9d30	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Fresenius Kabi USA, LLC	da858849-1d18-4d38-b53d-d4dd1cd8fabc	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	30f43d3b-c944-4f25-b5d3-009294944962	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Keppra	LEVETIRACETAM	UCB, Inc.	3ca9df05-a506-4ec8-a4fe-320f1219ab21	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
LEVETIRACETAM Extended-release	LEVETIRACETAM	Omnivium Pharmaceuticals LLC	1a31134d-6b63-4d14-8445-0ed132e6c88d	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Northwind Health Company, LLC	fc4c72e2-9cba-88d9-e053-6394a90a0426	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	deca634a-651e-4c70-9fc3-b0087b537b0a	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	c3daf220-9741-41c4-b89d-e06cee36dac6	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cranbury Pharmaceuticals, LLC	b1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b	2025-12-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Method Pharmaceuticals, LLC	47cfe577-b4cb-d35e-e063-6394a90ad8c4	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
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	Guardian Drug Company	e77162ff-0ff9-45ca-95fc-da6ea24ce5a2	2025-12-02	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.