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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 204734

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NDA 204734 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 four 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. Six suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for 204734

Tradename:	FOSRENOL
Applicant:	Takeda Pharms Usa
Ingredient:	lanthanum carbonate
Patents:	3
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204734

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 204734

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734	NDA	Takeda Pharmaceuticals America, Inc.	54092-256	54092-256-02	9 CARTON in 1 PACKAGE (54092-256-02) / 10 POWDER in 1 CARTON (54092-256-01)
FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734	NDA	Takeda Pharmaceuticals America, Inc.	54092-257	54092-257-02	9 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 750MG BASE
Approval Date:	Sep 24, 2014	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 26, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Dec 1, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Dec 1, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204734

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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