Orange Book product · Brand (NDA)

RECLAST

ZOLEDRONIC ACID

Brand (NDA)NDA 021817TE APRX SANDOZ

Apr 16, 2007

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 16, 2007
19 yr 5 mo ago
Today
Patent 7932241 expires
Listed drug product patent expiration.
Feb 05, 2028
in 1 yr 8 mo
Patent 7932241*PED expires
Listed listed patent expiration.
Aug 05, 2028
in 2 yr 2 mo

Active ingredient

ZOLEDRONIC ACID

Strength

EQ 5MG BASE/100ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 021817

Product number

001

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
7932241	Feb 05, 2028	in 1 yr 8 mo	Product
7932241*PED	Aug 05, 2028	in 2 yr 2 mo