Application 091399

Type: ANDA
Sponsor: LUPIN LTD

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 42.

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
A091399-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-09-12
A091399-002	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
A091399-001	AB
A091399-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091399-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091399-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-09-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091399-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091399-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091399-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091399-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091399-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091399-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091399-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091399-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091399-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091399-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091399-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091399-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091399-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091399-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091399-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091399-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091399-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091399-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091399-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091399-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091399-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091399-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091399-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091399-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091399-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091399-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091399-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091399-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091399-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	BluePoint Laboratories	402b488c-1733-4bf7-a7a8-b60805b022c9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091399 application number: ANDA091399 ndc (product): 68001-114 ndc (product): 68001-113
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	18648f51-a37c-41e1-b451-123bc0cf5446	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091399 application number: ANDA091399 ndc (product): 68180-117 ndc (product): 68180-118

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57297-117	Levetiracetam	Levetiracetam	LUPIN LIMITED	ANDA	Current
57297-118	Levetiracetam	Levetiracetam	LUPIN LIMITED	ANDA	Current
68001-113	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-113	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-113	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-113	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-114	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-114	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-114	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68001-114	Levetiracetam	Levetiracetam	BluePoint Laboratories	ANDA	Current
68180-117	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-117	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-117	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-117	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-118	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-118	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-118	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-118	Levetiracetam	Levetiracetam	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-0648	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current
70518-0648	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43251	ORIG	2012-06-22
31527	ORIG	2011-09-21