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Details for New Drug Application (NDA): 021468

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NDA 021468 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 five 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 eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for NDA: 021468

Tradename:
FOSRENOL
Applicant:
Shire Llc
Ingredient:
lanthanum carbonate
Patents:3
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021468

Mechanism of ActionPhosphate 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 Shire US Manufacturing 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 Shire US Manufacturing Inc. 54092-253 54092-253-90 6 BOTTLE in 1 PACKAGE (54092-253-90) > 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrengthEQ 250MG BASE
Approval Date:Oct 26, 2004TE:RLD:No
Patent:7,465,465Patent Expiration:Aug 26, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:5,968,976Patent Expiration:Oct 26, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE
Patent:7,381,428Patent Expiration:Aug 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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