Application 090484

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	1GM	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
A090484-001	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB		2010-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090484-001	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 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	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090484-001	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2010-08-05	`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	A090484-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090484-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090484-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090484-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090484-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090484-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090484-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090484-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090484-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090484-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090484-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090484-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090484-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090484-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090484-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090484-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090484-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090484-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090484-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090484-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090484-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090484-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090484-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090484-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090484-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090484-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090484-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090484-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090484-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090484-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090484-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090484-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090484-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090484-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090484-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090484-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090484-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090484-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090484-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090484-001	AB	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 3 of 9 · 166 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	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Sun Pharmaceutical Industries, Inc.	bf412e94-ca36-4da9-83d7-fb0f1323cf21	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	02e237ff-a3e0-40fe-a3d0-9d8802855c71	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM solution	LEVETIRACETAM	Chartwell RX, LLC	61eb57a9-5df2-4426-9f0c-a75e2f356b11	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	REMEDYREPACK INC.	9bdef24b-c50e-4e6a-8650-59d78009f472	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	DIRECT RX	c3b62114-a590-f4db-e053-2995a90a9d30	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Fresenius Kabi USA, LLC	da858849-1d18-4d38-b53d-d4dd1cd8fabc	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	30f43d3b-c944-4f25-b5d3-009294944962	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Keppra	LEVETIRACETAM	UCB, Inc.	3ca9df05-a506-4ec8-a4fe-320f1219ab21	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
LEVETIRACETAM Extended-release	LEVETIRACETAM	Omnivium Pharmaceuticals LLC	1a31134d-6b63-4d14-8445-0ed132e6c88d	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Northwind Health Company, LLC	fc4c72e2-9cba-88d9-e053-6394a90a0426	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	deca634a-651e-4c70-9fc3-b0087b537b0a	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	c3daf220-9741-41c4-b89d-e06cee36dac6	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cranbury Pharmaceuticals, LLC	b1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b	2025-12-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Method Pharmaceuticals, LLC	47cfe577-b4cb-d35e-e063-6394a90ad8c4	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Advanced Rx of Tennessee, LLC	45a07f44-078d-0513-e063-6394a90a1629	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Advanced Rx of Tennessee, LLC	45a03a43-04db-9138-e063-6394a90a12fa	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Granules Pharmaceuticals Inc.	b4781ec4-43ad-4052-9a6a-b24fda119b32	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Guardian Drug Company	e77162ff-0ff9-45ca-95fc-da6ea24ce5a2	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam Extended-Release	LEVETIRACETAM	Golden State Medical Supply, Inc.	5dde1889-a217-4493-9a71-9fd39ed04630	2025-11-24	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2167	Levetiracetam	Levetiracetam	Actavis Elizabeth LLC	ANDA	Current
42043-193	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42254-277	Levetiracetam	Levetiracetam	Rebel Distributors Corp	ANDA	Current