FDA Orange Book · active-ingredient family
Carmustine
Carmustine is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CARMUSTINE · NDA 215000
3
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · implant, injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARMUSTINERLD×2 | ACCORD HLTHCARE | NDA 215000 | — | May 16, 2022 | |
| GLIADELRLD | AZURITY | NDA 020637 | — | Sep 23, 1996 | |
| BICNURLD | AVET LIFESCIENCES | NDA 017422 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARMUSTINE | ALEMBIC | ANDA 215730 | AP | Oct 20, 2023 | |
| CARMUSTINE | MSN | ANDA 214814 | AP | May 11, 2023 | |
| CARMUSTINE | PHARMOBEDIENT | ANDA 215368 | — | Mar 03, 2023 | |
| CARMUSTINE | ACCORD HLTHCARE | ANDA 214117 | — | Dec 27, 2022 | |
| CARMUSTINE | INGENUS PHARMS LLC | ANDA 211011 | — | Jun 21, 2022 | |
| CARMUSTINE | MEITHEAL | ANDA 213460 | AP | Aug 02, 2021 | |
| CARMUSTINE | HENGRUI PHARMA | ANDA 211202 | — | Mar 12, 2021 | |
| CARMUSTINE | DR REDDYS | ANDA 213207 | AP | Oct 22, 2020 | |
| CARMUSTINE | PENN LIFE | ANDA 209278 | AP | Apr 02, 2019 | |
| CARMUSTINE | AMNEAL | ANDA 211229 | AP | Oct 16, 2018 | |
| CARMUSTINE | NAVINTA LLC | ANDA 210179 | AP | Sep 11, 2018 |
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.
Carmustine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
