Orange Book product · Brand (NDA)

INFUGEM

GEMCITABINE HYDROCHLORIDE

Brand (NDA)NDA 208313DISCN SUN PHARM

Jul 16, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 16, 2018
8 yr 1 mo ago
Today
Patent 9241948 expires
Listed drug product patent expiration.
Jul 01, 2033
in 7 yr 2 mo

Active ingredient

GEMCITABINE HYDROCHLORIDE

Strength

EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208313

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
9241948	Jul 01, 2033	in 7 yr 2 mo	Product