Orange Book product · Brand (NDA)

RENVELA

SEVELAMER CARBONATE

Brand (NDA)NDA 022318TE ABRX GENZYME

Aug 12, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 12, 2009
17 yr 1 mo ago
Today
Patent 9095509 expires
Listed drug product patent expiration.
Dec 06, 2030
in 4 yr 6 mo

Active ingredient

SEVELAMER CARBONATE

Strength

800MG/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Application

NDA 022318

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
9095509	Dec 06, 2030	in 4 yr 6 mo	Product