U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214719
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription AB No No
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription AB No No
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/08/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ERLOTINIB HYDROCHLORIDE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 214719 ALEMBIC PHARMS LTD
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 208396 APOTEX
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 216342 EUGIA PHARMA
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 214366 MSN
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 208488 NATCO PHARMA LTD
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 091002 RISING
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 211960 SHILPA
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 210300 SUN PHARM
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 091059 TEVA PHARMS USA INC
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 213065 ZYDUS PHARMS
TARCEVA ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 021743 OSI PHARMS

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 214719 ALEMBIC PHARMS LTD
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 208396 APOTEX
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 216342 EUGIA PHARMA
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 214366 MSN
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 208488 NATCO PHARMA LTD
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 091002 RISING
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 211960 SHILPA
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 210300 SUN PHARM
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 091059 TEVA PHARMS USA INC
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 213065 ZYDUS PHARMS
TARCEVA ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 021743 OSI PHARMS

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 214719 ALEMBIC PHARMS LTD
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 208396 APOTEX
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 216342 EUGIA PHARMA
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 214366 MSN
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 208488 NATCO PHARMA LTD
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 091002 RISING
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 211960 SHILPA
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 210300 SUN PHARM
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 091059 TEVA PHARMS USA INC
ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 213065 ZYDUS PHARMS
TARCEVA ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription Yes AB 021743 OSI PHARMS
Back to Top