FDA Orange Book · active-ingredient family
Fludarabine phosphate
Fludarabine phosphate is approved as 3 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FLUDARABINE PHOSPHATE · NDA 022137
3
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUDARABINE PHOSPHATERLD | CAPLIN ONE LABS | NDA 022137 | — | Sep 21, 2007 | |
| FLUDARARLD | GENZYME CORP | NDA 020038 | — | Apr 18, 1991 | |
| OFORTA | SANOFI AVENTIS US | NDA 022273 | — | Dec 18, 2008 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUDARABINE PHOSPHATE | ACTAVIS LLC | ANDA 203738 | — | Feb 28, 2017 | |
| FLUDARABINE PHOSPHATE | RISING | ANDA 200648 | — | Oct 16, 2012 | |
| FLUDARABINE PHOSPHATE | EXTROVIS | ANDA 200647 | — | Dec 21, 2011 | |
| FLUDARABINE PHOSPHATE | AREVA PHARMS | ANDA 090724 | AP1 | Sep 27, 2010 | |
| FLUDARABINE PHOSPHATE | ACTAVIS TOTOWA | ANDA 078610 | AP | Feb 11, 2009 | |
| FLUDARABINE PHOSPHATE | FRESENIUS KABI USA | ANDA 078393 | AP1 | Oct 15, 2007 | |
| FLUDARABINE PHOSPHATE | FRESENIUS KABI USA | ANDA 078544 | AP | Oct 15, 2007 | |
| FLUDARABINE PHOSPHATE | HOSPIRA | ANDA 077790 | — | Apr 06, 2007 | |
| FLUDARABINE PHOSPHATE | SAGENT PHARMS INC | ANDA 076661 | AP1 | Apr 28, 2004 | |
| FLUDARABINE PHOSPHATE | HIKMA | ANDA 076349 | AP | Aug 28, 2003 |
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.
Fludarabine phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
