Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019763

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IFEX (IFOSFAMIDE)
1GM/VIAL
Marketing Status: Prescription

Active Ingredient: IFOSFAMIDE
Proprietary Name: IFEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N019763
Product Number: 001
Approval Date: Dec 30, 1988
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

IFEX (IFOSFAMIDE)
3GM/VIAL
Marketing Status: Prescription

Active Ingredient: IFOSFAMIDE
Proprietary Name: IFEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3GM/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N019763
Product Number: 002
Approval Date: Dec 30, 1988
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

IFEX/MESNEX KIT (IFOSFAMIDE; MESNA)
1GM/VIAL;100MG/ML
Marketing Status: Discontinued

Active Ingredient: IFOSFAMIDE; MESNA
Proprietary Name: IFEX/MESNEX KIT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL;100MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019763
Product Number: 003
Approval Date: Oct 10, 1992
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

IFEX/MESNEX KIT (IFOSFAMIDE; MESNA)
3GM/VIAL;100MG/ML
Marketing Status: Discontinued

Active Ingredient: IFOSFAMIDE; MESNA
Proprietary Name: IFEX/MESNEX KIT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3GM/VIAL;100MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019763
Product Number: 004
Approval Date: Oct 10, 1992
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information