Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091059
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
08/28/2015 ORIG-2 Tentative Approval

Label is not available on this site.

08/28/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ERLOTINIB HYDROCHLORIDE

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 211083 ACCORD HLTHCARE
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 091002 MYLAN
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 211960 SHILPA MEDICARE LTD
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
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 211083 ACCORD HLTHCARE
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 091002 MYLAN
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 211960 SHILPA MEDICARE LTD
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
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

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