Application 021468

Type: NDA
Sponsor: SHIRE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 250MG BASE	No	No
002	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 500MG BASE	Yes	No
003	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 750MG BASE	Yes	No
004	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 1GM BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-252	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-252	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-252	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-252	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79530	SUPPL	2024-09-03
79516	SUPPL	2024-09-02
79509	SUPPL	2024-08-30
76788	SUPPL	2023-12-13
76781	SUPPL	2023-12-13
74224	SUPPL	2023-05-11
74218	SUPPL	2023-05-11
62913	SUPPL	2020-05-12
62912	SUPPL	2020-05-12
62910	SUPPL	2020-05-12
56675	SUPPL	2018-12-07
56412	SUPPL	2018-11-12
56411	SUPPL	2018-11-12
56356	SUPPL	2018-11-08
37012	SUPPL	2016-02-26
5462	SUPPL	2016-02-26
37011	SUPPL	2014-09-26
27874	SUPPL	2014-09-26
27873	SUPPL	2012-11-05
15541	SUPPL	2012-11-02
15540	SUPPL	2011-09-07
5461	SUPPL	2011-09-07
37010	SUPPL	2011-04-29
27872	SUPPL	2011-04-29
15539	SUPPL	2011-04-29
5460	SUPPL	2011-04-29
42183	SUPPL	2011-01-04
21675	SUPPL	2011-01-04
5459	SUPPL	2008-10-28
27871	SUPPL	2008-04-11
27870	SUPPL	2006-03-23
21674	ORIG	2005-01-28
15538	ORIG	2004-11-01
5458	ORIG	2004-10-29

Application 021468

Related Records#

Application Products#

NDC Listings For This Application#

Documents#