FDA Orange Book · active-ingredient family
Flumazenil
Flumazenil is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ROMAZICON · NDA 020073
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROMAZICONRLD×2 | HOFFMANN LA ROCHE | NDA 020073 | — | Dec 20, 1991 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUMAZENIL×2 | SAGENT PHARMS | ANDA 090584 | AP | Aug 28, 2012 | |
| FLUMAZENIL×2 | HIKMA FARMACEUTICA | ANDA 078527 | AP | Mar 23, 2009 | |
| FLUMAZENIL×2 | RISING | ANDA 078595 | AP | May 13, 2008 | |
| FLUMAZENIL×2 | SANDOZ | ANDA 077071 | AP | May 03, 2005 | |
| FLUMAZENIL×2 | BAXTER HLTHCARE CORP | ANDA 076755 | AP | Oct 12, 2004 | |
| FLUMAZENIL×2 | DR REDDYS | ANDA 076589 | — | Oct 12, 2004 | |
| FLUMAZENIL×2 | FRESENIUS KABI USA | ANDA 076955 | AP | Oct 12, 2004 | |
| FLUMAZENIL×2 | HIKMA | ANDA 076256 | AP | Oct 12, 2004 | |
| FLUMAZENIL×2 | HIKMA | ANDA 076787 | — | Oct 12, 2004 |
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.
Flumazenil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
