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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 NDA: 019763

Tradename:
IFEX
Applicant:
Baxter Hlthcare
Ingredient:
ifosfamide
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Dec 30, 1988TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/VIAL
Approval Date:Dec 30, 1988TE:APRLD:No

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019763

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
IFEX/MESNEX KIT
ifosfamide; mesna
INJECTABLE;INJECTION019763-004Oct 10, 19925,696,172► subscribe
Baxter Hlthcare
IFEX/MESNEX KIT
ifosfamide; mesna
INJECTABLE;INJECTION019763-003Oct 10, 19925,696,172► subscribe
Baxter Hlthcare
IFEX/MESNEX KIT
ifosfamide; mesna
INJECTABLE;INJECTION019763-004Oct 10, 19924,220,660► subscribe
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