Product Details for ANDA 203380
IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
40MG/2ML (20MG/ML)
Marketing Status: Prescription
100MG/5ML (20MG/ML)
Marketing Status: Prescription
300MG/15ML (20MG/ML)
Marketing Status: Prescription
40MG/2ML (20MG/ML)
Marketing Status: Prescription
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: AP
Application Number: A203380
Product Number: 001
Approval Date: May 3, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
IRINOTECAN HYDROCHLORIDE (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: AP
Application Number: A203380
Product Number: 001
Approval Date: May 3, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
100MG/5ML (20MG/ML)
Marketing Status: Prescription
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: AP
Application Number: A203380
Product Number: 002
Approval Date: May 3, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
IRINOTECAN HYDROCHLORIDE (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: AP
Application Number: A203380
Product Number: 002
Approval Date: May 3, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
300MG/15ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: IRINOTECAN HYDROCHLORIDE
Proprietary Name: IRINOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 300MG/15ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203380
Product Number: 003
Approval Date: May 3, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: IRINOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 300MG/15ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203380
Product Number: 003
Approval Date: May 3, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information