Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076078
Company: FRESENIUS KABI USA

Products on ANDA 076078

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IFOSFAMIDE	IFOSFAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
IFOSFAMIDE	IFOSFAMIDE	3GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076078

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076078.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2025	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/19/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/19/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076078

IFOSFAMIDE

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