Orange Book product · Brand (NDA)
CARMUSTINE
CARMUSTINE
At a glance
May 16, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 16, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CARMUSTINE
Strength
50MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215000
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 1996GLIADELBrand (NDA)
NDA 020637 · AZURITY
- —BICNUBrand (NDA)
NDA 017422 · AVET LIFESCIENCES
- 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.
