Orange Book product · Brand (NDA)

FIRVANQ KIT

VANCOMYCIN HYDROCHLORIDE

Brand (NDA)NDA 208910TE AARX AZURITY

Jan 26, 2018

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 26, 2018
8 yr 6 mo ago
Today
Patent 10493028 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10688046 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959946 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959947 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959947 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959948 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959948 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959949 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959949 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 11638692 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 50MG BASE/ML

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Application

NDA 208910

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
10493028	Mar 13, 2035	in 8 yr 10 mo	Product
10688046	Mar 13, 2035	in 8 yr 10 mo	Product
10959946	Mar 13, 2035	in 8 yr 10 mo	Product
10959947	Mar 13, 2035	in 8 yr 10 mo	ProductU-3104
10959947	Mar 13, 2035	in 8 yr 10 mo	ProductU-3105
10959948	Mar 13, 2035	in 8 yr 10 mo	ProductU-3104
10959948	Mar 13, 2035	in 8 yr 10 mo	ProductU-3105
10959949	Mar 13, 2035	in 8 yr 10 mo	ProductU-3105
10959949	Mar 13, 2035	in 8 yr 10 mo	ProductU-3104
11638692	Mar 13, 2035	in 8 yr 10 mo	Product