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Generated: April 18, 2019

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Details for New Drug Application (NDA): 204734

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NDA 204734 describes FOSRENOL, which is a drug marketed by Shire Dev Llc and Shire Llc 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. Three suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for 204734
Tradename:FOSRENOL
Applicant:Shire Dev Llc
Ingredient:lanthanum carbonate
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 204734
Mechanism of ActionPhosphate 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 Shire US Manufacturing 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 Shire US Manufacturing 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:RXDosage:POWDER;ORALStrengthEQ 750MG BASE
Approval Date:Sep 24, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 26, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 1, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 1, 2030Product Flag?YSubstance Flag?Delist Request?

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