Product Details for NDA 021743
TARCEVA (ERLOTINIB HYDROCHLORIDE)
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ERLOTINIB HYDROCHLORIDE
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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 LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
TARCEVA (ERLOTINIB HYDROCHLORIDE)
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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 LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ERLOTINIB HYDROCHLORIDE
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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 LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
TARCEVA (ERLOTINIB HYDROCHLORIDE)
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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 LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ERLOTINIB HYDROCHLORIDE
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021743
Product Number: 003
Approval Date: Nov 18, 2004
Applicant Holder Full Name: OSI PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TARCEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021743
Product Number: 003
Approval Date: Nov 18, 2004
Applicant Holder Full Name: OSI PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information