Application 091261

Type: ANDA
Sponsor: APOTEX INC

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 44.

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
A091261-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-09-12
A091261-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091261-001	AB
A091261-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091261-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091261-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091261-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091261-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091261-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091261-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091261-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091261-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091261-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091261-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091261-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091261-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091261-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091261-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091261-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091261-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091261-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091261-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091261-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091261-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091261-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091261-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091261-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091261-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091261-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091261-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091261-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091261-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091261-002	AB	1	`4b0b4de00fa7…`

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 8 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	Patrin Pharma, Inc.	49117cee-a96c-4593-91a7-8a133e3f0939	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	MAJOR PHARMACEUTICALS	6913c611-4994-4501-8ed9-45161f90373e	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Natco Pharma USA LLC	34af3602-0188-4d2e-904b-2e40000bb45c	2023-08-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Armas Pharmaceuticals Inc.	7be45c40-8d75-4c40-97a4-95067129bc2a	2023-07-24	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	a0ad8200-70c9-4f4f-86c5-4a8c6c9f0223	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	57b9dccb-6ee6-4e89-ab26-4c478e2df2b5	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Fresenius Kabi USA, LLC	cc4a06f1-6509-4650-b20c-259a39353733	2022-02-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Fresenius Kabi USA, LLC	cc41696c-9cf0-4410-bacc-09132ee805ce	2022-01-24	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM INJECTION	Dr.Reddy's Laboratories Inc	be8ec971-c4f1-3e53-77e1-8337d9d506eb	2021-12-31	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
Levetiracetam	LEVETIRACETAM INJECTION	Dr.Reddy's Laboratories Inc	0a9234b7-46b1-8e6c-a992-90f86cfb6e00	2021-12-31	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
Levetiracetam	LEVETIRACETAM	Prinston Pharmaceutical Inc.	d818ef84-9b3e-434b-92d9-910cfa8af7da	2020-08-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Dr. Reddy's Laboratories Limited	1f3c04d9-cccb-06a3-a0f3-f7c9228ee743	2018-12-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Dr. Reddy's Laboratories Limited	ee03507b-cb35-4fe9-ae7b-85ea89f876f0	2018-12-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Exelan Pharmaceuticals, Inc.	28c0e61e-1af9-410a-9fa9-b71bf99a776b	2018-11-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Amneal Pharmaceuticals LLC	d7932a2c-a3b7-46df-a306-1f17716160a0	2017-11-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60429-349	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-349	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-349	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-349	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-349	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-350	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-350	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-350	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-350	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60429-350	Levetiracetam	levetiracetam	Golden State Medical Supply, Inc.	ANDA	Current
60505-3280	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3280	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3280	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3280	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3517	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3517	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3517	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3517	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9328	ORIG	2011-09-28