FDA Orange Book · active-ingredient family
Amifostine
Amifostine: 1 brand, 2 generics; first approved Dec 08, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- LEGACYNDA 02022119952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx — 375MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- AMIFOSTINEEUGIA PHARMA SPECLTSANDA 2043632017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — - AMIFOSTINESUN PHARMANDA 0771262008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued —
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
31 yr 2 mo ago
Most recent approval
9 yr 3 mo ago
Approvals span 1995–2017 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Amifostine: 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.
