FDA Orange Book · active-ingredient family
Ifosfamide
Ifosfamide: 1 brand, 5 generics; first approved Dec 30, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- IFEXRLDBAXTER HLTHCARENDA 01976319882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Rx AP 3GM/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (5)
Abbreviated applications
- IFOSFAMIDEEXTROVISANDA 20168920122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/20ML (50MG/ML) INJECTABLE INJECTION Discontinued — 3GM/60ML (50MG/ML) INJECTABLE INJECTION Discontinued — - IFOSFAMIDEHIKMAANDA 07661920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP 3GM/60ML (50MG/ML) INJECTABLE INJECTION Rx AP - IFOSFAMIDEFRESENIUS KABI USAANDA 09018120092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/20ML (50MG/ML) INJECTABLE INJECTION Discontinued — 3GM/60ML (50MG/ML) INJECTABLE INJECTION Discontinued — - IFOSFAMIDERSMEITHEALANDA 07665720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP 3GM/60ML (50MG/ML) INJECTABLE INJECTION Rx AP - IFOSFAMIDERSFRESENIUS KABI USAANDA 07607820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Rx AP 3GM/VIAL INJECTABLE INJECTION Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
38 yr 4 mo ago
Most recent approval
14 yr 1 mo ago
Approvals span 1988–2012 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Ifosfamide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
