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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 091059


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NDA 091059 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 twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Summary for 091059
Tradename:ERLOTINIB HYDROCHLORIDE
Applicant:Teva Pharms Usa Inc
Ingredient:erlotinib hydrochloride
Patents:0
Pharmacology for NDA: 091059
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 091059
Suppliers and Packaging for NDA: 091059
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091059 ANDA Teva Pharmaceuticals USA, Inc. 0093-7662 0093-7662-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7662-56)
ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091059 ANDA Teva Pharmaceuticals USA, Inc. 0093-7663 0093-7663-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7663-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 9, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 28, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Aug 28, 2015TE:ABRLD:No

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