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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203843

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NDA 203843 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. Eleven suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

Summary for 203843

Tradename:	ERLOTINIB HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	erlotinib hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 203843

Antineoplastic Agents
Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Sep 13, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Sep 13, 2024	TE:	AB	RLD:	No

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