FDA Orange Book · active-ingredient family
Gatifloxacin
Gatifloxacin is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZYMAXID · NDA 022548
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYMAXIDRLD | ABBVIE | NDA 022548 | AT | May 18, 2010 | |
| ZYMARRLD | ALLERGAN | NDA 021493 | — | Mar 28, 2003 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GATIFLOXACIN | CAPLIN | ANDA 213542 | AT | Nov 03, 2021 | |
| GATIFLOXACIN | RISING | ANDA 206446 | — | Jun 08, 2018 | |
| GATIFLOXACIN | SANDOZ | ANDA 204227 | AT | Jul 11, 2016 | |
| GATIFLOXACIN | HIKMA | ANDA 203189 | — | Sep 03, 2014 | |
| GATIFLOXACIN | LUPIN | ANDA 202653 | — | Aug 28, 2013 | |
| GATIFLOXACIN | APOTEX INC | ANDA 079084 | — | Aug 19, 2011 |
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.
Gatifloxacin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
