Orange Book product · Brand (NDA)

DALVANCE

DALBAVANCIN HYDROCHLORIDE

Brand (NDA)NDA 021883TE APRX ABBVIE

May 23, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 23, 2014
12 yr 3 mo ago
Today
Patent 6900175 expires
Listed method-of-use patent (U-3499) expiration.
May 23, 2028
in 1 yr 11 mo

Active ingredient

DALBAVANCIN HYDROCHLORIDE

Strength

EQ 500MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Application

NDA 021883

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
6900175	May 23, 2028	in 1 yr 11 mo	U-3499