Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090101

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IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
500MG/25ML (20MG/ML)
Marketing Status: Prescription

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: IRINOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/25ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090101
Product Number: 001
Approval Date: Nov 26, 2008
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
40MG/2ML (20MG/ML)
Marketing Status: Discontinued

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: IRINOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/2ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090101
Product Number: 002
Approval Date: Feb 27, 2008
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
100MG/5ML (20MG/ML)
Marketing Status: Discontinued

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: IRINOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/5ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090101
Product Number: 003
Approval Date: Feb 27, 2008
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information