An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091059
Company: TEVA PHARMS USA INC

Products on ANDA 091059

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2020	ORIG-2	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.

Therapeutic Equivalents for ANDA 091059

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
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	203843	CHARTWELL RX
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	209267	HETERO LABS LTD V
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	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	091059	TEVA PHARMS USA INC
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	213065	ZYDUS 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
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	209267	HETERO LABS LTD V
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	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	091059	TEVA PHARMS USA INC
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	213065	ZYDUS 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
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	203843	CHARTWELL RX
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	209267	HETERO LABS LTD V
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	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	091059	TEVA PHARMS USA INC
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	213065	ZYDUS PHARMS

Top