FDA Orange Book · active-ingredient family
Bleomycin sulfate
Bleomycin sulfate is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BLENOXANE · NDA 050443
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BLENOXANERLD×2 | BRISTOL MYERS SQUIBB | NDA 050443 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | CIPLA | ANDA 209439 | — | Mar 11, 2019 | |
| BLEOMYCIN SULFATE×2 | MEITHEAL | ANDA 205030 | AP | Apr 20, 2018 | |
| BLEOMYCIN SULFATE×2 | FRESENIUS KABI USA | ANDA 065185 | AP | Jan 28, 2008 | |
| BLEOMYCIN SULFATE | PHARMACHEMIE BV | ANDA 065201 | — | Dec 13, 2007 | |
| BLEOMYCIN SULFATE×2 | HIKMA | ANDA 065042 | AP | Oct 17, 2001 | |
| BLEOMYCIN SULFATE×2 | TEVA PHARMS USA | ANDA 065033 | — | Jun 27, 2000 | |
| BLEOMYCIN SULFATE×2 | HOSPIRA | ANDA 065031 | AP | Mar 10, 2000 | |
| BLEOMYCIN SULFATE×2 | TEVA PARENTERAL | ANDA 064084 | — | Jun 01, 1996 |
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.
Bleomycin sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
