FDA Orange Book · active-ingredient family
Busulfan
Busulfan: 2 brands, 15 generics; first approved Feb 04, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
15
Listed patents
0
Presentations
17
Brand (NDA) products
Originator applications
Generic (ANDA) products (15)
Abbreviated applications
- BUSULFANPRINSTON INCANDA 2152352024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANEUGIA PHARMAANDA 2151022024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANMEITHEALANDA 2121272020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANAPOTEXANDA 2104482019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANSHILPAANDA 2109312019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANACCORD HLTHCARE INCANDA 2101482019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANNEXUSANDA 2077942019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANARTHUR GRPANDA 2051062018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANHOSPIRAANDA 2056722018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANPHARMOBEDIENTANDA 2051842018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANAMNEALANDA 2095802017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANACTAVISANDA 2051392017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANMYLAN INSTITUTIONALANDA 2085362017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Discontinued — - BUSULFANPHARMASCIENCE INCANDA 2070502017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML INJECTABLE INJECTION Rx AP - BUSULFANAM REGENTANDA 2022592015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG/ML 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
27 yr 11 mo ago
Most recent approval
1 yr 11 mo ago
Approvals span 1999–2024 across 17 FDA applications.
Brand (NDA) 212%
Generic (ANDA) 1588%
Busulfan: 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.
