Orange Book product · Generic (ANDA)
FLUMAZENIL
FLUMAZENIL
At a glance
Aug 28, 2012
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 28, 2012
14 yr ago
Today
Pharmaceutical detail
Active ingredient
FLUMAZENIL
Strength
0.5MG/5ML (0.1MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 090584
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUMAZENIL
- 1991ROMAZICONBrand (NDA)
NDA 020073 · HOFFMANN LA ROCHE
- 2009FLUMAZENILGeneric (ANDA)
ANDA 078527 · HIKMA FARMACEUTICA
- 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.
