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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

ProductApplicantApplicationTEApproved
IFEXRLD×2BAXTER HLTHCARENDA 019763APDec 30, 1988

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
IFOSFAMIDE×2EXTROVISANDA 201689Nov 26, 2012
IFOSFAMIDE×2HIKMAANDA 076619APJun 29, 2011
IFOSFAMIDE×2FRESENIUS KABI USAANDA 090181Sep 22, 2009
IFOSFAMIDE×2MEITHEALANDA 076657APApr 04, 2007
IFOSFAMIDE×2FRESENIUS KABI USAANDA 076078APMay 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.