Orange Book product · Brand (NDA)

FOSRENOL

LANTHANUM CARBONATE

Brand (NDA)NDA 204734RX TAKEDA PHARMS USA

Sep 24, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 24, 2014
11 yr 11 mo ago
Today
Patent 8980327 expires
Listed drug product patent expiration.
Dec 01, 2030
in 4 yr 6 mo
Patent 9023397 expires
Listed drug product patent expiration.
Dec 01, 2030
in 4 yr 6 mo

Active ingredient

LANTHANUM CARBONATE

Strength

EQ 1GM BASE

Dosage form

POWDER

Route

ORAL

TE code

Not listed

Application

NDA 204734

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8980327	Dec 01, 2030	in 4 yr 6 mo	Product
9023397	Dec 01, 2030	in 4 yr 6 mo	Product