Orange Book product · Brand (NDA)
ONCOVIN
VINCRISTINE SULFATE
At a glance
Mar 07, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 07, 1984
42 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
VINCRISTINE SULFATE
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 014103
Product number
003
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.
- 2012MARQIBO KITBrand (NDA)
NDA 202497 · ACROTECH
- 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.
