FDA Orange Book · active-ingredient family
Vinorelbine tartrate
Vinorelbine tartrate is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NAVELBINE · NDA 020388
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAVELBINERLD | PIERRE FABRE | NDA 020388 | — | Dec 23, 1994 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VINORELBINE TARTRATE | INGENUS PHARMS LLC | ANDA 208997 | — | Aug 05, 2019 | |
| VINORELBINE TARTRATE | DR REDDYS | ANDA 202017 | AP | Sep 12, 2013 | |
| VINORELBINE TARTRATE | JIANGSU HANSOH PHARM | ANDA 091106 | AP | Sep 26, 2012 | |
| VINORELBINE TARTRATE | RISING | ANDA 200148 | — | Aug 31, 2012 | |
| VINORELBINE TARTRATE | ACTAVIS TOTOWA | ANDA 078011 | AP | Jul 22, 2009 | |
| VINORELBINE TARTRATE | EBEWE PHARMA | ANDA 078408 | — | Feb 13, 2008 | |
| VINORELBINE TARTRATE | HOSPIRA | ANDA 076827 | — | Jun 02, 2005 | |
| VINORELBINE TARTRATE | FRESENIUS KABI USA | ANDA 076849 | — | Apr 18, 2005 | |
| VINORELBINE TARTRATE | HIKMA | ANDA 076461 | AP | Dec 11, 2003 | |
| VINORELBINE TARTRATE | HIKMA | ANDA 075992 | AP | Jun 10, 2003 | |
| VINORELBINE TARTRATE | TEVA PHARMS USA | ANDA 076028 | — | Feb 03, 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.
Vinorelbine tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
