Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212501

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CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
500MG/2.5ML (200MG/ML)
Marketing Status: Prescription

Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG/2.5ML (200MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212501
Product Number: 001
Approval Date: Jul 30, 2020
Applicant Holder Full Name: INGENUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
1GM/5ML (200MG/ML)
Marketing Status: Prescription

Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/5ML (200MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212501
Product Number: 002
Approval Date: Jul 30, 2020
Applicant Holder Full Name: INGENUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
2GM/10ML (200MG/ML)
Marketing Status: Prescription

Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYCLOPHOSPHAMIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2GM/10ML (200MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212501
Product Number: 003
Approval Date: Nov 19, 2021
Applicant Holder Full Name: INGENUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information