Orange Book product · Brand (NDA)

VIBATIV

TELAVANCIN HYDROCHLORIDE

Brand (NDA)NDA 022110RX CUMBERLAND

Sep 11, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 11, 2009
17 yr ago
Today
Patent 7531623 expires
Listed drug substance patent expiration.
Jan 01, 2027
in 7 mo

Active ingredient

TELAVANCIN HYDROCHLORIDE

Strength

EQ 750MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022110

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
7531623	Jan 01, 2027	in 7 mo	Substance