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 5 of 9 · 165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	c4b27429-50a3-467c-a5ff-7e49a01a1088	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Precision Dose, Inc.	6fb1e4d3-520c-44f1-a09d-d7b779e4edfd	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Rising Pharma Holdings, Inc.	db423b93-d7c2-4cf2-829b-24b657f27f93	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam ER	LEVETIRACETAM	REMEDYREPACK INC.	2d57f22f-fecc-466e-a444-87708c7c2f80	2025-08-14	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	e31c6830-4647-4481-b4f1-494a52c48b1b	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Prasco Laboratories	dd175fa3-1d7a-4542-affd-988ac5bba1db	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	2d307850-0ed5-4f32-ac62-0e1e2fe27a7a	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Keppra	LEVETIRACETAM	UCB, Inc.	c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Keppra XR	LEVETIRACETAM	UCB, Inc.	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM IN SODIUM CHLORIDE	Caplin Steriles Limited	563171fb-df26-4f95-853a-fd7707da291c	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	0348fec4-d919-4307-ac90-35360819bc00	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	OWP Pharmaceuticals, Inc.	e662bf5b-c81c-4bcd-ba2e-552df95ca6f9	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hikma Pharmaceuticals USA Inc.	097e5606-dd5e-4518-ab97-f71f68786444	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Civica, Inc.	1591c690-f4ed-44b7-a9d0-bff1fbb4bfef	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Mylan Pharmaceuticals Inc.	0a987d59-560f-4650-96ec-31aec81953b5	2025-04-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	QUAGEN PHARMACEUTICALS LLC	1d67cb3c-1173-4dce-a79b-a3c36934ab2e	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Hikma Pharmaceuticals USA Inc.	8d767545-1eb9-45a5-bd16-e8a66e628fea	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Solco Healthcare US, LLC	cfe618ae-f7de-43d8-a754-3ce0a08c48ee	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
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

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