Application 207958

Type: NDA
Sponsor: APRECIA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPRITAM	LEVETIRACETAM	TABLET, FOR SUSPENSION;ORAL	250MG	Yes	No
002	SPRITAM	LEVETIRACETAM	TABLET, FOR SUSPENSION;ORAL	500MG	Yes	No
003	SPRITAM	LEVETIRACETAM	TABLET, FOR SUSPENSION;ORAL	750MG	Yes	No
004	SPRITAM	LEVETIRACETAM	TABLET, FOR SUSPENSION;ORAL	1GM	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207958-001	SPRITAM	LEVETIRACETAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31
N207958-002	SPRITAM	LEVETIRACETAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31
N207958-003	SPRITAM	LEVETIRACETAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31
N207958-004	SPRITAM	LEVETIRACETAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207958-001	11160786	2034-03-14		Drug product	2021-11-30
N207958-001	9339489	2034-03-14	U-1850	Drug product	2017-07-25
N207958-001	9669009	2034-03-14	U-1850		2017-06-28
N207958-001	9669009	2034-03-14	U-2021		2017-06-28
N207958-001	9669009	2034-03-14	U-2022		2017-06-28
N207958-002	11160786	2034-03-14		Drug product	2021-11-30
N207958-002	9339489	2034-03-14	U-1850	Drug product	2016-06-16
N207958-002	9669009	2034-03-14	U-1850		2017-06-28
N207958-002	9669009	2034-03-14	U-2021		2017-06-28
N207958-002	9669009	2034-03-14	U-2022		2017-06-28
N207958-003	11160786	2034-03-14		Drug product	2021-11-30
N207958-003	9339489	2034-03-14	U-1850	Drug product	2016-06-16
N207958-003	9669009	2034-03-14	U-1850		2017-06-28
N207958-003	9669009	2034-03-14	U-2021		2017-06-28
N207958-003	9669009	2034-03-14	U-2022		2017-06-28
N207958-004	11160786	2034-03-14		Drug product	2021-11-30
N207958-004	9339489	2034-03-14	U-1850	Drug product	2016-06-16
N207958-004	9669009	2034-03-14	U-1850		2017-06-28
N207958-004	9669009	2034-03-14	U-2021		2017-06-28
N207958-004	9669009	2034-03-14	U-2022		2017-06-28

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207958-001	SPRITAM	250MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207958-002	SPRITAM	500MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207958-003	SPRITAM	750MG	TABLET, FOR SUSPENSION / ORAL	RLD	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207958-004	SPRITAM	1GM	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2015-07-31	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 788 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207958-001	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9339489	2034-03-14	U-1850	Drug product	2017-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-001	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-002	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-003	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	11160786	2034-03-14		Drug product	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9669009	2034-03-14	U-1850		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9669009	2034-03-14	U-2021		2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207958-004	9669009	2034-03-14	U-2022		2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9339489	2034-03-14	U-1850	Drug product	2017-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-001	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-002	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-003	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	11160786	2034-03-14		Drug product	2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9339489	2034-03-14	U-1850	Drug product	2016-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9669009	2034-03-14	U-1850		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9669009	2034-03-14	U-2021		2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207958-004	9669009	2034-03-14	U-2022		2017-06-28	`31067a03dcf5…`

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
Spritam	LEVETIRACETAM	Aprecia Pharmaceuticals, LLC	be651c31-383f-11e4-916c-0800200c9a66	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207958 application number: NDA207958 ndc (product): 43485-103 ndc (product): 43485-101 ndc (product): 43485-102 ndc (product): 43485-104
Levetiracetam	LEVETIRACETAM	Prasco Laboratories	dd175fa3-1d7a-4542-affd-988ac5bba1db	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207958 application number: NDA207958

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-101	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-102	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-103	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current
43485-104	Spritam	levetiracetam	Aprecia Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82711	SUPPL	2025-06-30
82702	SUPPL	2025-06-30
78821	SUPPL	2024-06-18
78820	SUPPL	2024-06-18
78815	SUPPL	2024-06-18
77813	SUPPL	2024-03-13
77802	SUPPL	2024-03-13
75466	SUPPL	2023-09-15
75337	SUPPL	2023-08-31
65954	SUPPL	2021-01-21
65953	SUPPL	2021-01-21
65948	SUPPL	2021-01-21
55787	SUPPL	2018-10-02
55786	SUPPL	2018-10-02
55486	SUPPL	2018-09-14
48699	SUPPL	2017-06-12
48697	SUPPL	2017-06-12
48696	SUPPL	2017-06-12
23045	ORIG	2016-05-27
19978	SUPPL	2016-02-02
10636	SUPPL	2016-02-02
40603	ORIG	2015-08-04
32870	ORIG	2015-08-04