Orange Book product · Brand (NDA)
ROMAZICON
FLUMAZENIL
At a glance
Dec 20, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
FLUMAZENIL
Strength
0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020073
Product number
002
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.
- 2012FLUMAZENILGeneric (ANDA)
ANDA 090584 · SAGENT PHARMS
- 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.
