FDA Orange Book · active-ingredient family
Vincristine sulfate
Vincristine sulfate is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MARQIBO KIT · NDA 202497
2
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, injectable, liposomal
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MARQIBO KITRLD | ACROTECH | NDA 202497 | — | Aug 09, 2012 | |
| ONCOVINRLD×3 | LILLY | NDA 014103 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VINCRISTINE SULFATE | FRESENIUS KABI USA | ANDA 076401 | — | Oct 28, 2003 | |
| VINCRISTINE SULFATE | FRESENIUS KABI USA | ANDA 076296 | — | Dec 20, 2002 | |
| VINCRISTINE SULFATE PFS | TEVA PHARMS USA | ANDA 075493 | — | Sep 01, 1999 | |
| VINCREX | BRISTOL MYERS SQUIBB | ANDA 070867 | — | Jul 12, 1988 | |
| VINCRISTINE SULFATE PFS | HOSPIRA | ANDA 071484 | — | Apr 19, 1988 | |
| VINCRISTINE SULFATE | HOSPIRA | ANDA 071559 | — | Apr 11, 1988 | |
| VINCRISTINE SULFATE | HOSPIRA | ANDA 071560 | — | Apr 11, 1988 | |
| VINCRISTINE SULFATE | HOSPIRA | ANDA 071561 | — | Apr 11, 1988 | |
| VINCASAR PFS | TEVA PARENTERAL | ANDA 071426 | — | Jul 17, 1987 | |
| VINCRISTINE SULFATE | ABIC | ANDA 070873 | — | Feb 19, 1987 | |
| VINCRISTINE SULFATE | ABRAXIS PHARM | ANDA 070411 | — | Sep 10, 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.
Vincristine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
