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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019763
Company: BAXTER HLTHCARE

Products on NDA 019763

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IFEX	IFOSFAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	No
IFEX	IFOSFAMIDE	3GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	No
IFEX/MESNEX KIT	IFOSFAMIDE; MESNA	1GM/VIAL;100MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
IFEX/MESNEX KIT	IFOSFAMIDE; MESNA	3GM/VIAL;100MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019763

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/1987	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2024	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019763s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019763Orig1s021ltr.pdf
07/30/2018	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019763s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019763Orig1s020ltr.pdf
08/28/2014	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019763s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019763Orig1s019ltr.pdf
03/01/2012	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019763s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019763s017ltr.pdf
03/23/2011	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019763s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019763s016ltr.pdf
11/21/2001	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/06/2001	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/20/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/23/1996	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1995	SUPPL-7	Labeling		Label is not available on this site.
06/15/1995	SUPPL-5	Labeling		Label is not available on this site.
11/10/1992	SUPPL-4	Labeling		Label is not available on this site.
11/10/1992	SUPPL-3	Labeling		Label is not available on this site.
01/27/1992	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1990	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019763

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019763s021lbl.pdf
07/30/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019763s020lbl.pdf
08/28/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019763s019lbl.pdf
03/01/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019763s017lbl.pdf
03/23/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019763s016lbl.pdf

Therapeutic Equivalents for NDA 019763

IFEX

INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IFEX	IFOSFAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	019763	BAXTER HLTHCARE
IFOSFAMIDE	IFOSFAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076078	FRESENIUS KABI USA

INJECTABLE;INJECTION; 3GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IFEX	IFOSFAMIDE	3GM/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	019763	BAXTER HLTHCARE
IFOSFAMIDE	IFOSFAMIDE	3GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076078	FRESENIUS KABI USA

IFEX/MESNEX KIT

There are no Therapeutic Equivalents.

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