Application 078918

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

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	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078918-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB		2009-04-29
A078918-002	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB		2009-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078918-001	AB
A078918-002	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 3 · 86 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	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078918-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078918-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-04-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A078918-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078918-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078918-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078918-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078918-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078918-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078918-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078918-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078918-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078918-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078918-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078918-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078918-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078918-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078918-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078918-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078918-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078918-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078918-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078918-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078918-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078918-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078918-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078918-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078918-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078918-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078918-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078918-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078918-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078918-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078918-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078918-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078918-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078918-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078918-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078918-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078918-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078918-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078918-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078918-002	AB	1	`74a2ff9319b5…`

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 9 · 163 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Aryeh Pharma corp	4f8ffd81-f814-f288-e063-6394a90a5eb5	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Safecor Health LLC	e72a7410-13fd-40e4-befb-052d0455e038	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	7696961e-dfff-422a-b72f-e31ceeac10af	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
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

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-703	levetiracetam	levetiracetam	Cadila Healthcare Limited	ANDA	Current
65841-703	levetiracetam	levetiracetam	Zydus Lifesciences Limited	ANDA	Current
65841-703	levetiracetam	levetiracetam	Cadila Healthcare Limited	ANDA	Current
65841-703	levetiracetam	levetiracetam	Cadila Healthcare Limited	ANDA	Current
65841-704	levetiracetam	levetiracetam	Cadila Healthcare Limited	ANDA	Current
65841-704	levetiracetam	levetiracetam	Zydus Lifesciences Limited	ANDA	Current
65841-704	levetiracetam	levetiracetam	Cadila Healthcare Limited	ANDA	Current
65841-704	levetiracetam	levetiracetam	Cadila Healthcare Limited	ANDA	Current
68382-165	levetiracetam	levetiracetam	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-165	levetiracetam	levetiracetam	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-165	levetiracetam	levetiracetam	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-165	levetiracetam	levetiracetam	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-168	levetiracetam	levetiracetam	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-168	levetiracetam	levetiracetam	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-168	levetiracetam	levetiracetam	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-168	levetiracetam	levetiracetam	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current