Application 076919

Type: ANDA
Sponsor: MYLAN

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 1.

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
A076919-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04
A076919-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04
A076919-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076919-002	AB
A076919-003	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 · 123 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	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2008-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2008-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076919-001	LEVETIRACETAM	250MG	TABLET / ORAL		2008-11-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076919-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076919-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076919-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076919-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076919-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076919-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076919-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076919-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076919-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076919-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076919-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076919-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076919-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076919-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076919-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076919-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076919-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076919-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076919-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076919-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076919-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076919-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076919-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076919-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076919-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076919-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076919-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076919-003	AB	1	`74a2ff9319b5…`

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	e1b14939-7262-40dc-a334-2b3b72c88d47	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919 ndc (product): 55154-5699
Levetiracetam	LEVETIRACETAM	Safecor Health LLC	e72a7410-13fd-40e4-befb-052d0455e038	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919
Levetiracetam	LEVETIRACETAM	Mylan Institutional Inc.	08e1bfea-7f3f-42d9-823d-f75080e664ff	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919 ndc (product): 51079-821
Levetiracetam	LEVETIRACETAM	Mylan Pharmaceuticals Inc.	0a987d59-560f-4650-96ec-31aec81953b5	2025-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076919 application number: ANDA076919 ndc (product): 0378-5617 ndc (product): 0378-5615

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5613	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5613	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5613	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5613	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5613	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5615	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5615	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5615	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5615	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5615	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5617	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5617	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5617	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5617	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5617	Levetiracetam	levetiracetam	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7550	Levetiracetam	levetiracetam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7551	Levetiracetam	levetiracetam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7552	Levetiracetam	levetiracetam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-820	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
51079-821	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
51079-821	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
51079-821	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
51079-821	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
51079-822	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
51079-822	Levetiracetam	levetiracetam	Mylan Institutional Inc.	ANDA	Current
53808-0376	Levetiracetam	levetiracetam	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5698	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
55154-5698	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
55154-5699	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
55154-5699	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
55154-5699	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
55154-5699	Levetiracetam	levetiracetam	Cardinal Health 107, LLC	ANDA	Current
55154-5699	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
55154-5699	Levetiracetam	levetiracetam	Cardinal Health	ANDA	Current
70518-0430	Levetiracetam	levetiracetam	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23841	ORIG	2008-11-25