Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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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