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

NDC Listings For This Application#

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

Application 207958

Related Records#

Application Products#

NDC Listings For This Application#

Documents#