Application 202167

Type: ANDA
Sponsor: DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	LEVETIRACETAM	LEVETIRACETAM	TABLET, EXTENDED RELEASE;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202167-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL			2015-09-04
A202167-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL			2015-09-04

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 · 82 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	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202167-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202167-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202167-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202167-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202167-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202167-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202167-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202167-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202167-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202167-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202167-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202167-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202167-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202167-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202167-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202167-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202167-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202167-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202167-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202167-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202167-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202167-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202167-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202167-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202167-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202167-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202167-002	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202167-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202167-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202167-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202167-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202167-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202167-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202167-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202167-002	AB	1	`cb3db0bc1861…`

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 · 165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Micro Labs Limited	1e3cfafe-5784-4ec6-91dc-cd74b01d0bb4	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM 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
Levetiracetam	LEVETIRACETAM IN SODIUM CHLORIDE	Eugia US LLC	e5eb4c89-8ee9-4474-9cb1-c3b3dc262a4a	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-387	Levetiracetam	Levetiracetam	AvKARE, Inc.	ANDA	Current
42291-388	Levetiracetam	Levetiracetam	AvKARE, Inc.	ANDA	Current
69076-500	Levetiracetam	Levetiracetam	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-500	Levetiracetam	Levetiracetam	Florida Pharmaceutical Products, LLC.	ANDA	Current
69076-750	Levetiracetam	Levetiracetam	Quinn Pharmaceuticals, LLC	ANDA	Current
69076-750	Levetiracetam	Levetiracetam	Florida Pharmaceutical Products, LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9982	ORIG	2015-09-09