Orange Book product · Brand (NDA)

BINOSTO

ALENDRONATE SODIUM

Brand (NDA)NDA 202344RX RADIUS

Mar 12, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 12, 2012
14 yr 6 mo ago
Today
Patent 9592195 expires
Listed drug product patent expiration.
Dec 05, 2031
in 5 yr 7 mo

Active ingredient

ALENDRONATE SODIUM

Strength

EQ 70MG BASE

Dosage form

TABLET, EFFERVESCENT

Route

ORAL

TE code

Not listed

Application

NDA 202344

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
9592195	Dec 05, 2031	in 5 yr 7 mo	Product