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 43.

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 · 129 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	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077319-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077319-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077319-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-20	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A077319-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077319-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077319-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077319-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077319-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077319-003	AB	1	`caaa826d4ba7…`
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…`

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 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	ScieGen Pharmaceuticals, Inc.	1d71212b-ac97-4a61-8192-8e8303540019	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	423d2185-0931-4414-8864-7594000809ee	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam Extended-Release	LEVETIRACETAM	ScieGen Pharmaceuticals, Inc	3e32f341-9926-47a3-a942-d8b9bfa7a55b	2024-07-12	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	American Health Packaging	031a32e1-675a-4efe-a66b-40beb4fe5101	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Amneal Pharmaceuticals LLC	5c4877cc-52bc-4f98-a995-0aa9439da742	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam ER	LEVETIRACETAM	Westminster Pharmaceuticals, LLC	c508a392-0603-477d-8a45-3ec550371111	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Hospira, Inc.	f1935bc8-30ce-4b51-8a4c-0f12ce9000a6	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	bc8b413f-2f07-4e6a-bb8e-a1f2119ae1cf	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Actavis Pharma, Inc.	5cb4a1db-f32d-44af-8985-0a94ca506468	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
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

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 · 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