Orange Book product · Brand (NDA)

GANZYK-RTU

GANCICLOVIR

Brand (NDA)NDA 209347DISCN EXELA PHARMA

Feb 17, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 17, 2017
9 yr 6 mo ago
Today
Patent 9486530 expires
Listed drug product patent expiration.
Sep 02, 2034
in 8 yr 4 mo

Active ingredient

GANCICLOVIR

Strength

500MG/250ML (2MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 209347

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
9486530	Sep 02, 2034	in 8 yr 4 mo	Product