Product Details for ANDA 204555
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
500MG/VIAL
Marketing Status: Prescription
1GM/VIAL
Marketing Status: Prescription
2GM/VIAL
Marketing Status: Prescription
500MG/VIAL
Marketing Status: Prescription
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204555
Product Number: 001
Approval Date: Oct 31, 2014
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204555
Product Number: 001
Approval Date: Oct 31, 2014
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
1GM/VIAL
Marketing Status: Prescription
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204555
Product Number: 002
Approval Date: Oct 31, 2014
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204555
Product Number: 002
Approval Date: Oct 31, 2014
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
2GM/VIAL
Marketing Status: Prescription
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204555
Product Number: 003
Approval Date: Oct 31, 2014
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A204555
Product Number: 003
Approval Date: Oct 31, 2014
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information