Application 079063

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	SOLUTION;ORAL	100MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079063-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079063-001	AA

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 2 · 41 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	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079063-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2009-01-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A079063-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079063-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079063-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079063-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079063-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079063-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079063-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079063-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079063-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079063-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079063-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079063-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079063-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079063-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079063-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079063-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079063-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079063-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079063-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079063-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079063-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079063-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079063-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079063-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079063-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079063-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079063-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079063-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079063-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079063-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079063-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079063-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079063-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079063-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079063-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079063-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079063-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079063-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079063-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079063-001	AA	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	94d042f7-93b9-43bd-9ace-cfc61903b4d7	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079063 application number: ANDA079063
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	74ccc9f1-b957-4b1b-9464-1b5e3318c916	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079063 application number: ANDA079063
Levetiracetam	LEVETIRACETAM	NorthStar Rx LLC	483a42b9-c8f3-4f8b-98be-fcac5ab23c7c	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079063 application number: ANDA079063 ndc (product): 16714-358
Levetiracetam	LEVETIRACETAM	Aurobindo Pharma Limited	f65ec19d-b90e-452e-b761-c68b1cf2c892	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079063 application number: ANDA079063 ndc (product): 65862-250

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-358	Levetiracetam	Levetiracetam	NorthStar Rx LLC	ANDA	Current
16714-358	Levetiracetam	Levetiracetam	NorthStar Rx LLC	ANDA	Current
16714-358	Levetiracetam	Levetiracetam	NorthStar Rx LLC	ANDA	Current
16714-358	Levetiracetam	Levetiracetam	NorthStar Rx LLC	ANDA	Current
16714-358	Levetiracetam	Levetiracetam	NorthStar Rx LLC	ANDA	Current
63739-019	LEVETIRACETAM	levetiracetam	McKesson Corporation DBA SKY Packaging	ANDA	Current
63739-019	Levetiracetam	Levetiracetam	McKesson Corporation	ANDA	Current
63739-019	Levetiracetam	Levetiracetam	McKesson Corporation dba SKY Packaging	ANDA	Current
65862-250	Levetiracetam	Levetiracetam	Aurobindo Pharma Limited	ANDA	Current
65862-250	Levetiracetam	Levetiracetam	Aurobindo Pharma Limited	ANDA	Current
65862-250	Levetiracetam	Levetiracetam	Aurobindo Pharma Limited	ANDA	Current
65862-250	Levetiracetam	Levetiracetam	Aurobindo Pharma Limited	ANDA	Current
65862-250	Levetiracetam	Levetiracetam	Aurobindo Pharma Limited	ANDA	Current
70518-3582	Levetiracetam	Levetiracetam	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9215	ORIG	2009-01-21