Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021743

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TARCEVA (ERLOTINIB HYDROCHLORIDE)
EQ 25MG BASE Marketing Status: Prescription

Active Ingredient: ERLOTINIB HYDROCHLORIDE
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021743
Product Number: 001
Approval Date: Nov 18, 2004
Applicant Holder Full Name: OSI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TARCEVA (ERLOTINIB HYDROCHLORIDE)
EQ 100MG BASE Marketing Status: Prescription

Active Ingredient: ERLOTINIB HYDROCHLORIDE
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021743
Product Number: 002
Approval Date: Nov 18, 2004
Applicant Holder Full Name: OSI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TARCEVA (ERLOTINIB HYDROCHLORIDE)
EQ 150MG BASE Marketing Status: Prescription

Active Ingredient: ERLOTINIB HYDROCHLORIDE
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021743
Product Number: 003
Approval Date: Nov 18, 2004
Applicant Holder Full Name: OSI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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