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 6 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals Inc.	8c16bc7b-672c-420a-a457-350060533375	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	c82313cb-744f-45ef-b74c-1bdd055b2193	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Kesin Pharma Corporation	30a4626d-74f3-6385-e063-6394a90a2950	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c2177034-e164-453c-be02-1cf91ce27a07	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	American Health Packaging	3be7c30b-f35d-4dde-8bf8-24f67bd70865	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	2d596153-c49b-273f-e063-6294a90ac663	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Torrent Pharmaceuticals Limited	6ab24168-058d-496e-9023-da8ee6353eb3	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	NCS HealthCare of KY, LLC dba Vangard Labs	dfb7c640-623e-43d1-8ee8-479dccd53d0a	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Novadoz Pharmaceuticals LLC	1c4450a1-6c05-4b45-a733-c19b4e861970	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	8b74b8bc-d95c-4471-8f74-c3117243bf89	2024-12-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	American Health Packaging	fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Ascend Laboratories, LLC	591dd9f1-3681-4b2f-b096-7536826e3648	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	8a8472dc-b97e-445d-bf51-b6e618cae1b6	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	NorthStar Rx LLC	483a42b9-c8f3-4f8b-98be-fcac5ab23c7c	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Aurobindo Pharma Limited	f65ec19d-b90e-452e-b761-c68b1cf2c892	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	XLCare Pharmaceuticals Inc.	567f09e6-ccd5-4688-a22b-0bc66a5fe31e	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	f7c96494-6cb2-4d00-8c5a-5bec4e0c70c0	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	Novadoz Pharmaceuticals LLC	1ec4c05d-7fba-4c02-a3bf-4343a8a421d5	2024-08-28	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	b738377c-035e-4b2e-9909-0a8fe07aa0fb	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM ORAL	Camber Pharmaceuticals, Inc.	0bc8468f-832c-4e71-95a2-db464d4d54bc	2024-08-03	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