Details for New Drug Application (NDA): 021468

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NDA 021468 describes FOSRENOL, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSRENOL profile page.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for 021468

Tradename:	FOSRENOL
Applicant:	Takeda Pharms Usa
Ingredient:	lanthanum carbonate
Patents:	0

Pharmacology for NDA: 021468

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 021468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468	NDA	Takeda Pharmaceuticals America, Inc.	54092-252	54092-252-90	2 BOTTLE in 1 PACKAGE (54092-252-90) / 45 TABLET, CHEWABLE in 1 BOTTLE (54092-252-45)
FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468	NDA	Takeda Pharmaceuticals America, Inc.	54092-253	54092-253-90	6 BOTTLE in 1 PACKAGE (54092-253-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Oct 26, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Oct 26, 2004	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 750MG BASE
Approval Date:	Nov 23, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021468

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	5,968,976	⤷ Get Started Free
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004	7,381,428	⤷ Get Started Free
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	7,465,465	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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