Application 077319

Type: ANDA
Sponsor: OXFORD PHARMS

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077319-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20
A077319-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20
A077319-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077319-001	AB
A077319-002	AB
A077319-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077319-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077319-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077319-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077319-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077319-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077319-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077319-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077319-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077319-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077319-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077319-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077319-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077319-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077319-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077319-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077319-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077319-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077319-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077319-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077319-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077319-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077319-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077319-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077319-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077319-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077319-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077319-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077319-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077319-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077319-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077319-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077319-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077319-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077319-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077319-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077319-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077319-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077319-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077319-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077319-001	AB	1	`8072bd15b7f6…`

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 2 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	c12d8af3-39a8-4690-8d47-43dec70b7579	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Injecta Medcial LLC	52fa0eec-3dd9-59ca-e063-6394a90a9791	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	e1b14939-7262-40dc-a334-2b3b72c88d47	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	419b3dba-ae21-4268-ac8b-342aaa609554	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	c4a3018a-3cd8-4e07-a840-099ceae01c91	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	51b66893-f7d6-8f9d-e063-6294a90a8e9b	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	df661166-325d-4071-9bc1-f7bf992996d2	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	ASCLEMED USA INC.	a3c57d82-511c-4c7d-84ff-f791f931f576	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	513f422f-1637-5f41-e063-6294a90ab548	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	65a76fcb-31a8-4c5a-9ffe-5393fc4dac34	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	ba18ead0-69d7-453a-badc-cd6ad376d18e	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	5037a86a-21f2-d793-e063-6394a90a2cb5	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM IN SODIUM CHLORIDE	Somerset Therapeutics, LLC	2b37c579-ebe7-4ce1-8a34-03e974a77439	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
LEVETIRACETAM	LEVETIRACETAM	Bionpharma Inc.	1d75b15e-881c-a00f-e063-6394a90a4138	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0125	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-0126	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23867	ORIG	2009-04-14