Assyro AI

FDA Orange Book · active-ingredient family

Ifosfamide; mesna

Ifosfamide; mesna is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:IFEX/MESNEX KIT · NDA 019763

1

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
IFEX/MESNEX KIT×2BAXTER HLTHCARENDA 019763Oct 10, 1992

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
IFOSFAMIDE/MESNA KIT×2TEVA PHARMS USAANDA 075874Feb 26, 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; mesna — 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.