Application 078993

Type: ANDA
Sponsor: AUROBINDO PHARMA

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	TE codes	Approval date
A078993-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078993-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078993-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15
A078993-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078993-001	AB
A078993-002	AB
A078993-003	AB
A078993-004	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 5 · 172 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	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A078993-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078993-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078993-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078993-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078993-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078993-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078993-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078993-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078993-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078993-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078993-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078993-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078993-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078993-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078993-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078993-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078993-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078993-004	AB	1	`5bbf6a4d5a75…`

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 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	0348fec4-d919-4307-ac90-35360819bc00	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Unit Dose Solutions, Inc.	551626eb-3282-e439-e063-6294a90a8314	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	53843871-23e3-974e-e063-6394a90a8042	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	51b66893-f7d6-8f9d-e063-6294a90a8e9b	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Coupler LLC	5037a86a-21f2-d793-e063-6394a90a2cb5	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	6e31e766-6504-4f20-8831-1953363cace0	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	01aef7f7-6092-4e39-8451-dc02d8db9254	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	58ed7049-44c6-4f97-9174-c0e1504586a6	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	5eb7bea5-c95f-4a38-a5bb-c20d1549c797	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	c4b27429-50a3-467c-a5ff-7e49a01a1088	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	8b74b8bc-d95c-4471-8f74-c3117243bf89	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	American Health Packaging	fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993 ndc (product): 68084-882
Levetiracetam	LEVETIRACETAM	American Health Packaging	031a32e1-675a-4efe-a66b-40beb4fe5101	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993
Levetiracetam	LEVETIRACETAM	Aurobindo Pharma Limited	2471ee03-d747-4113-86d0-1aa93c8f3eba	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078993 application number: ANDA078993

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 3 of 3 · 181 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68084-882	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-882	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-882	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-893	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-893	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-893	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-893	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68084-893	Levetiracetam	Levetiracetam	American Health Packaging	ANDA	Current
68258-7089	Levetiracetam	Levetiracetam	Dispensing Solutions, Inc.	ANDA	Current
68788-7592	Levetiracetam	Levetiracetam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7592	Levetiracetam	Levetiracetam	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1961	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-1961	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-2026	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-2026	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-2026	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
71335-0139	Levetiracetam	Levetiracetam	Bryant Ranch Prepack	ANDA	Current
71335-0139	Levetiracetam	Levetiracetam	Bryant Ranch Prepack	ANDA	Current
71335-0139	Levetiracetam	Levetiracetam	Bryant Ranch Prepack	ANDA	Current
71335-0139	Levetiracetam	Levetiracetam	Bryant Ranch Prepack	ANDA	Current
71335-1194	Levetiracetam	Levetiracetam	Bryant Ranch Prepack	ANDA	Current