Application 201157

Type: ANDA
Sponsor: PHARM ASSOC

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
A201157-001	LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA		2015-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201157-001	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	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201157-001	LEVETIRACETAM	100MG/ML	SOLUTION / ORAL	AA	2015-06-04	`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	A201157-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201157-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201157-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201157-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201157-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201157-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201157-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201157-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201157-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201157-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201157-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201157-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201157-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201157-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201157-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201157-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201157-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201157-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201157-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201157-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201157-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201157-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201157-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201157-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201157-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201157-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201157-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201157-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201157-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201157-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201157-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201157-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201157-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201157-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201157-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201157-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201157-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201157-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201157-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201157-001	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	Cardinal Health 107, LLC	a91defd2-486b-4995-ba4c-640525ab575d	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	f924d55d-d7ec-4448-b54e-3a7eaf5a1cab	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157 ndc (product): 55154-5782
Levetiracetam	LEVETIRACETAM	Major Pharmaceuticals	423d2185-0931-4414-8864-7594000809ee	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157 ndc (product): 0904-7265
Levetiracetam	LEVETIRACETAM	PAI Holdings, LLC dba PAI Pharma	9dca1330-52ca-47a4-a134-ec55c9d5786d	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201157 application number: ANDA201157 ndc (product): 0121-1598 ndc (product): 0121-4799 ndc (product): 0121-2397 ndc (product): 0121-0799

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1598	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-2397	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4799	Levetiracetam	LEVETIRACETAM	Pharmaceutical Associates, Inc.	ANDA	Current
0904-7265	Levetiracetam	LEVETIRACETAM	MAJOR	ANDA	Current
55154-5782	Levetiracetam	LEVETIRACETAM	Cardinal Health	ANDA	Current
55154-5782	Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	ANDA	Current
55154-5782	Levetiracetam	LEVETIRACETAM	Cardinal Health	ANDA	Current
55154-5782	Levetiracetam	LEVETIRACETAM	Cardinal Health	ANDA	Current
55154-5782	Levetiracetam	LEVETIRACETAM	Cardinal Health	ANDA	Current
55154-9447	Levetiracetam	LEVETIRACETAM	Cardinal Health	ANDA	Current
63739-158	Levetiracetam	Levetiracetam	McKesson Corporation dba as SKY Packaging	ANDA	Current
70518-1969	Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	ANDA	Current
81646-116	Levetiracetam	LEVETIRACETAM	PINNACLE PHARMA LLC	ANDA	Current