Orange Book product · Brand (NDA)
GLIADEL
CARMUSTINE
At a glance
Sep 23, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 23, 1996
30 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CARMUSTINE
Strength
7.7MG
Dosage form
IMPLANT
Route
INTRACRANIAL
TE code
Not listed
Application
NDA 020637
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
- —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.
