You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 29, 2025

Details for New Drug Application (NDA): 208396

✉ Email this page to a colleague

« Back to Dashboard

NDA 208396 describes ERLOTINIB HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Chartwell Rx, Eugia Pharma, Hetero Labs Ltd V, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the ERLOTINIB HYDROCHLORIDE profile page.

The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

Summary for 208396

Tradename:	ERLOTINIB HYDROCHLORIDE
Applicant:	Apotex
Ingredient:	erlotinib hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 208396

Antineoplastic Agents
Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Nov 5, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Nov 5, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Nov 5, 2019	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.