FDA Orange Book · active-ingredient family
Ifosfamide
Ifosfamide is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IFEX · NDA 019763
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IFEXRLD×2 | BAXTER HLTHCARE | NDA 019763 | AP | Dec 30, 1988 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IFOSFAMIDE×2 | EXTROVIS | ANDA 201689 | — | Nov 26, 2012 | |
| IFOSFAMIDE×2 | HIKMA | ANDA 076619 | AP | Jun 29, 2011 | |
| IFOSFAMIDE×2 | FRESENIUS KABI USA | ANDA 090181 | — | Sep 22, 2009 | |
| IFOSFAMIDE×2 | MEITHEAL | ANDA 076657 | AP | Apr 04, 2007 | |
| IFOSFAMIDE×2 | FRESENIUS KABI USA | ANDA 076078 | AP | May 28, 2002 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ifosfamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

