Orange Book product · Brand (NDA)

TARCEVA

ERLOTINIB HYDROCHLORIDE

Brand (NDA)NDA 021743DISCN OSI PHARMS

View ERLOTINIB HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Nov 18, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 18, 2004
21 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

ERLOTINIB HYDROCHLORIDE

Strength

EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 021743

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo