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Generated: November 20, 2018

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Details for New Drug Application (NDA): 019763

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NDA 019763 describes IFEX/MESNEX KIT, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the IFEX/MESNEX KIT profile page.

The generic ingredient in IFEX/MESNEX KIT is ifosfamide; mesna. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ifosfamide; mesna profile page.
Summary for 019763
Tradename:IFEX/MESNEX KIT
Applicant:Baxter Hlthcare
Ingredient:ifosfamide; mesna
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019763
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 019763
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IFEX ifosfamide INJECTABLE;INJECTION 019763 NDA Baxter Healthcare Corporation 0338-3991 0338-3991-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3991-01) > 20 mL in 1 VIAL, SINGLE-DOSE
IFEX ifosfamide INJECTABLE;INJECTION 019763 NDA Baxter Healthcare Corporation 0338-3993 0338-3993-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3993-01) > 60 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1988TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1988TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1GM/VIAL;100MG/ML
Approval Date:Oct 10, 1992TE:RLD:No

Expired US Patents for NDA 019763

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare IFEX ifosfamide INJECTABLE;INJECTION 019763-001 Dec 30, 1988 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare IFEX ifosfamide INJECTABLE;INJECTION 019763-002 Dec 30, 1988 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare IFEX/MESNEX KIT ifosfamide; mesna INJECTABLE;INJECTION 019763-003 Oct 10, 1992 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare IFEX/MESNEX KIT ifosfamide; mesna INJECTABLE;INJECTION 019763-004 Oct 10, 1992 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare IFEX/MESNEX KIT ifosfamide; mesna INJECTABLE;INJECTION 019763-003 Oct 10, 1992 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare IFEX/MESNEX KIT ifosfamide; mesna INJECTABLE;INJECTION 019763-004 Oct 10, 1992 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare IFEX/MESNEX KIT ifosfamide; mesna INJECTABLE;INJECTION 019763-004 Oct 10, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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