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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 091002

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NDA 091002 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 091002

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

Medical Subject Heading (MeSH) Categories for 091002

Antineoplastic Agents
Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jun 11, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jun 11, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jun 11, 2014	TE:	AB	RLD:	No

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