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 4 of 9 · 165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Hp Halden Pharma AS	6951de41-4a16-4cca-8039-44fc81407081	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hp Halden Pharma AS	35bb1e5f-d5cd-4e7f-a056-48c0cf9ebd76	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	01aef7f7-6092-4e39-8451-dc02d8db9254	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	58ed7049-44c6-4f97-9174-c0e1504586a6	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	5eb7bea5-c95f-4a38-a5bb-c20d1549c797	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	bc12f0b0-e05c-48e4-ad08-0ff14a818a64	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	43df4156-0958-e496-e063-6294a90a5329	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	b9597cd5-5745-494a-bd72-93071ed221da	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Mylan Institutional Inc.	08e1bfea-7f3f-42d9-823d-f75080e664ff	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM solution	LEVETIRACETAM	Chartwell Governmental & Specialty RX, LLC.	e1ebd960-79a4-4632-b727-4e9811824113	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Eugia US LLC	3e43c17f-7e7e-4ccd-b321-1dd5e62cdafd	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	TAGI Pharma, Inc.	72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	18648f51-a37c-41e1-b451-123bc0cf5446	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	671a1ae1-f672-48da-8a69-94c147472003	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Spritam	LEVETIRACETAM	Aprecia Pharmaceuticals, LLC	be651c31-383f-11e4-916c-0800200c9a66	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	792db8dc-177b-4864-8600-12823819082d	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Quallent Pharmaceuticals Health LLC	3756f052-919c-4817-a56e-1091fd514d9d	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	NorthStar RxLLC	3884cb76-822b-400d-9b24-49c286c9b6f7	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Apotex Corp.	abc9fada-c5c2-4e07-fb8a-4d1518f7657e	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	SOHM, Inc.	0a688786-879b-4e27-a46a-5c86bbfa1292	2025-09-19	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 · 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