Application 205130

Type: ANDA
Sponsor: SCIEGEN PHARMS 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 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
A205130-001	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-27
A205130-002	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205130-001	AB
A205130-002	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 2 · 74 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	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205130-001	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205130-002	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A205130-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205130-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205130-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205130-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205130-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205130-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205130-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205130-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205130-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205130-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205130-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205130-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205130-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205130-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205130-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205130-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205130-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205130-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205130-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205130-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205130-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205130-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205130-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205130-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205130-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205130-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205130-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205130-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205130-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam ER	LEVETIRACETAM	REMEDYREPACK INC.	2d57f22f-fecc-466e-a444-87708c7c2f80	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130
Levetiracetam Extended-Release	LEVETIRACETAM	ScieGen Pharmaceuticals, Inc	3e32f341-9926-47a3-a942-d8b9bfa7a55b	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130 ndc (product): 50228-190 ndc (product): 50228-189
Levetiracetam ER	LEVETIRACETAM	Westminster Pharmaceuticals, LLC	c508a392-0603-477d-8a45-3ec550371111	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130 ndc (product): 69367-333 ndc (product): 69367-332
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	a0ad8200-70c9-4f4f-86c5-4a8c6c9f0223	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130 ndc (product): 71205-728
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	57b9dccb-6ee6-4e89-ab26-4c478e2df2b5	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205130 application number: ANDA205130 ndc (product): 71205-881 ndc (product): 71205-880

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-189	Levetiracetam	levetiracetam	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-189	Levetiracetam	levetiracetam	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-190	Levetiracetam	levetiracetam	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-190	Levetiracetam	levetiracetam	ScieGen Pharmaceuticals, Inc	ANDA	Current
69367-332	Levetiracetam	Levetiracetam	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-333	Levetiracetam	Levetiracetam	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-728	Levetiracetam	Levetiracetam	Proficient Rx LP	ANDA	Current
71205-880	Levetiracetam	Levetiracetam	Proficient Rx LP	ANDA	Current
71205-880	Levetiracetam	Levetiracetam	Proficient Rx LP	ANDA	Current
71205-881	Levetiracetam	Levetiracetam	Proficient Rx LP	ANDA	Current
71205-881	Levetiracetam	Levetiracetam	Proficient Rx LP	ANDA	Current