Orange Book product · Brand (NDA)
BICNU
CARMUSTINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CARMUSTINE
Strength
100MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 017422
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.
- 2022CARMUSTINEBrand (NDA)
NDA 215000 · ACCORD HLTHCARE
- 1996GLIADELBrand (NDA)
NDA 020637 · AZURITY
- 2023CARMUSTINEGeneric (ANDA)
ANDA 215730 · ALEMBIC
- 2023CARMUSTINEGeneric (ANDA)
ANDA 214814 · MSN
- 2023CARMUSTINEGeneric (ANDA)
ANDA 215368 · PHARMOBEDIENT
- 2022CARMUSTINEGeneric (ANDA)
ANDA 214117 · ACCORD HLTHCARE
- 2022CARMUSTINEGeneric (ANDA)
ANDA 211011 · INGENUS PHARMS LLC
- 2021CARMUSTINEGeneric (ANDA)
ANDA 213460 · MEITHEAL
- 2021CARMUSTINEGeneric (ANDA)
ANDA 211202 · HENGRUI PHARMA
- 2020CARMUSTINEGeneric (ANDA)
ANDA 213207 · DR REDDYS
- 2019CARMUSTINEGeneric (ANDA)
ANDA 209278 · PENN LIFE
- 2018CARMUSTINEGeneric (ANDA)
ANDA 211229 · 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.
