Drug application

ERLOTINIB HYDROCHLORIDE (ERLOTINIB HYDROCHLORIDE)

Drugs@FDA ANDA 091059 · TEVA PHARMS USA INC

Key facts

Drug name ERLOTINIB HYDROCHLORIDE
Active ingredients ERLOTINIB HYDROCHLORIDE
Application type ANDA
Application number 091059
Company TEVA PHARMS USA INC
Dosage forms TABLET, ORAL
Strength EQ 25MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 9, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

Browse all Drugs@FDA applications