Orange Book product · Brand (NDA)
MYLERAN
BUSULFAN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
BUSULFAN
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 009386
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1999BUSULFEXBrand (NDA)
NDA 020954 · OTSUKA PHARM
- 2024BUSULFANGeneric (ANDA)
ANDA 215235 · PRINSTON INC
- 2024BUSULFANGeneric (ANDA)
ANDA 215102 · EUGIA PHARMA
- 2020BUSULFANGeneric (ANDA)
ANDA 212127 · MEITHEAL
- 2019BUSULFANGeneric (ANDA)
ANDA 210448 · APOTEX
- 2019BUSULFANGeneric (ANDA)
ANDA 210931 · SHILPA
- 2019BUSULFANGeneric (ANDA)
ANDA 210148 · ACCORD HLTHCARE INC
- 2019BUSULFANGeneric (ANDA)
ANDA 207794 · NEXUS
- 2018BUSULFANGeneric (ANDA)
ANDA 205106 · ARTHUR GRP
- 2018BUSULFANGeneric (ANDA)
ANDA 205672 · HOSPIRA
- 2018BUSULFANGeneric (ANDA)
ANDA 205184 · PHARMOBEDIENT
- 2017BUSULFANGeneric (ANDA)
ANDA 209580 · AMNEAL
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.
