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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076078

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IFOSFAMIDE (IFOSFAMIDE)
1GM/VIAL
Marketing Status: Prescription
Active Ingredient: IFOSFAMIDE
Proprietary Name: IFOSFAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A076078
Product Number: 001
Approval Date: May 28, 2002
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
IFOSFAMIDE (IFOSFAMIDE)
3GM/VIAL
Marketing Status: Prescription
Active Ingredient: IFOSFAMIDE
Proprietary Name: IFOSFAMIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3GM/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A076078
Product Number: 002
Approval Date: May 28, 2002
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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