Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020571

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

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: CAMPTOSAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/2ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020571
Product Number: 001
Approval Date: Jun 14, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: CAMPTOSAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/5ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020571
Product Number: 002
Approval Date: Jun 14, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CAMPTOSAR (IRINOTECAN HYDROCHLORIDE)
300MG/15ML (20MG/ML)
Marketing Status: Prescription

Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: CAMPTOSAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 300MG/15ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020571
Product Number: 003
Approval Date: Aug 5, 2010
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information