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Last Updated: March 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091002


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NDA 091002 describes ERLOTINIB HYDROCHLORIDE, which is a drug marketed by Apotex, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa, and is included in six NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Summary for 091002
Tradename:ERLOTINIB HYDROCHLORIDE
Applicant:Mylan
Ingredient:erlotinib hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091002
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 091002
Suppliers and Packaging for NDA: 091002
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091002 ANDA Mylan Pharmaceuticals Inc. 0378-7131 0378-7131-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7131-93)
ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091002 ANDA Mylan Pharmaceuticals Inc. 0378-7132 0378-7132-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7132-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No
Regulatory Exclusivity Expiration:Nov 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No
Regulatory Exclusivity Expiration:Nov 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No
Regulatory Exclusivity Expiration:Nov 5, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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