Details for New Drug Application (NDA): 019763

✉ Email this page to a colleague

NDA 019763 describes IFEX/MESNEX KIT, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from three suppliers. 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. Three suppliers are 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

Pharmacology for NDA: 019763

Mechanism of Action	Alkylating 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1988	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1988	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL;100MG/ML
Approval Date:	Oct 10, 1992	TE:		RLD:	No

Expired US Patents for NDA 019763

Subscribe to access the full database, or Sign Up
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.