Orange Book product · Brand (NDA)
MARQIBO KIT
VINCRISTINE SULFATE
At a glance
Aug 09, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 09, 2012
14 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
VINCRISTINE SULFATE
Strength
5MG/5ML (1MG/ML)
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 202497
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —ONCOVINBrand (NDA)
NDA 014103 · LILLY
- 2003VINCRISTINE SULFATEGeneric (ANDA)
ANDA 076401 · FRESENIUS KABI USA
- 2002VINCRISTINE SULFATEGeneric (ANDA)
ANDA 076296 · FRESENIUS KABI USA
- 1999VINCRISTINE SULFATE PFSGeneric (ANDA)
ANDA 075493 · TEVA PHARMS USA
- 1988VINCREXGeneric (ANDA)
ANDA 070867 · BRISTOL MYERS SQUIBB
- 1988VINCRISTINE SULFATE PFSGeneric (ANDA)
ANDA 071484 · HOSPIRA
- 1988VINCRISTINE SULFATEGeneric (ANDA)
ANDA 071559 · HOSPIRA
- 1988VINCRISTINE SULFATEGeneric (ANDA)
ANDA 071560 · HOSPIRA
- 1988VINCRISTINE SULFATEGeneric (ANDA)
ANDA 071561 · HOSPIRA
- 1987VINCASAR PFSGeneric (ANDA)
ANDA 071426 · TEVA PARENTERAL
- 1987VINCRISTINE SULFATEGeneric (ANDA)
ANDA 070873 · ABIC
- 1986VINCRISTINE SULFATEGeneric (ANDA)
ANDA 070411 · ABRAXIS PHARM
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.
