FDA Orange Book · active-ingredient family
Dacarbazine
Dacarbazine is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DTIC-DOME · NDA 017575
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DTIC-DOMERLD×2 | BAYER HLTHCARE | NDA 017575 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DACARBAZINE | HOSPIRA | ANDA 075940 | — | Oct 18, 2001 | |
| DACARBAZINE×2 | HIKMA | ANDA 075812 | AP | Jun 15, 2001 | |
| DACARBAZINE×2 | FRESENIUS KABI USA | ANDA 075371 | — | Aug 27, 1999 | |
| DACARBAZINE×2 | MEITHEAL | ANDA 075259 | AP | Aug 27, 1998 | |
| DACARBAZINE | ABRAXIS PHARM | ANDA 070962 | — | Aug 28, 1986 | |
| DACARBAZINE | ABRAXIS PHARM | ANDA 070990 | — | Aug 28, 1986 |
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.
Dacarbazine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
