Orange Book product · Generic (ANDA)
FLUMAZENIL
FLUMAZENIL
At a glance
Mar 23, 2009
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2009
17 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUMAZENIL
Strength
1MG/10ML (0.1MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078527
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of FLUMAZENIL
- 1991ROMAZICONBrand (NDA)
NDA 020073 · HOFFMANN LA ROCHE
- 2012FLUMAZENILGeneric (ANDA)
ANDA 090584 · SAGENT PHARMS
- 2008FLUMAZENILGeneric (ANDA)
ANDA 078595 · RISING
- 2005FLUMAZENILGeneric (ANDA)
ANDA 077071 · SANDOZ
- 2004FLUMAZENILGeneric (ANDA)
ANDA 076755 · BAXTER HLTHCARE CORP
- 2004FLUMAZENILGeneric (ANDA)
ANDA 076589 · DR REDDYS
- 2004FLUMAZENILGeneric (ANDA)
ANDA 076955 · FRESENIUS KABI USA
- 2004FLUMAZENILGeneric (ANDA)
ANDA 076256 · HIKMA
- 2004FLUMAZENILGeneric (ANDA)
ANDA 076787 · HIKMA
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.
