FDA Orange Book · active-ingredient family
Ofloxacin
Ofloxacin is approved as 4 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FLOXIN OTIC · NDA 020799
4
Brand (NDA)
30
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution/drops, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLOXIN OTICRLD | DAIICHI | NDA 020799 | — | Dec 16, 1997 | |
| OCUFLOXRLD | ALLERGAN | NDA 019921 | AT | Jul 30, 1993 | |
| FLOXINRLD×3 | JANSSEN PHARMS | NDA 019735 | — | Dec 28, 1990 | |
| FLOXIN×5 | ORTHO MCNEIL PHARM | NDA 020087 | — | Mar 31, 1992 |
Generic (ANDA) products (30)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OFLOXACIN | MICRO LABS | ANDA 218557 | AT | Apr 08, 2026 | |
| OFLOXACIN | SOMERSET THERAPS LLC | ANDA 216328 | AT | Oct 15, 2024 | |
| OFLOXACIN | SOMERSET | ANDA 213597 | AT | Aug 01, 2024 | |
| OFLOXACIN | CAPLIN | ANDA 217904 | AT | Apr 12, 2024 | |
| OFLOXACIN | AMNEAL | ANDA 211524 | — | Mar 01, 2024 | |
| OFLOXACIN | CAPLIN | ANDA 217903 | AT | Jan 05, 2024 | |
| OFLOXACIN | MANKIND PHARMA | ANDA 215886 | AT | Nov 23, 2022 | |
| OFLOXACIN | MANKIND PHARMA | ANDA 216130 | AT | Jul 14, 2022 | |
| OFLOXACIN | FDC LTD | ANDA 215038 | AT | Jan 19, 2022 | |
| OFLOXACIN | AMNEAL | ANDA 211525 | AT | Aug 30, 2019 | |
| OFLOXACIN×3 | CADILA PHARMS LTD | ANDA 091656 | AB | Sep 18, 2014 | |
| OFLOXACIN | ALTAIRE PHARMS INC | ANDA 202692 | AT | Apr 29, 2013 | |
| OFLOXACIN | ALVOGEN | ANDA 090395 | — | Aug 11, 2009 | |
| OFLOXACIN | FDC LTD | ANDA 078559 | AT | Feb 25, 2009 | |
| OFLOXACIN | SANDOZ | ANDA 076848 | — | Nov 25, 2008 | |
| OFLOXACIN | SENTISS | ANDA 076407 | AT | Apr 15, 2008 | |
| OFLOXACIN | BAUSCH AND LOMB INC | ANDA 076128 | AT | Mar 17, 2008 | |
| OFLOXACIN | HIKMA | ANDA 076616 | — | Mar 17, 2008 | |
| OFLOXACIN | SANDOZ | ANDA 078222 | — | Mar 17, 2008 | |
| OFLOXACIN | APOTEX INC | ANDA 076527 | AT | Sep 28, 2007 | |
| OFLOXACIN×3 | DR REDDYS LABS LTD | ANDA 077098 | AB | Feb 10, 2006 | |
| OFLOXACIN | ALVOGEN | ANDA 076830 | — | Aug 31, 2004 | |
| OFLOXACIN | APOTEX INC | ANDA 076513 | AT | May 14, 2004 | |
| OFLOXACIN | BAUSCH AND LOMB | ANDA 076622 | AT | May 14, 2004 | |
| OFLOXACIN | EPIC PHARMA LLC | ANDA 076615 | — | May 14, 2004 | |
| OFLOXACIN | SANDOZ | ANDA 076231 | — | May 14, 2004 | |
| OFLOXACIN×3 | CHARTWELL RX | ANDA 076093 | — | Sep 02, 2003 | |
| OFLOXACIN×3 | RANBAXY LABS LTD | ANDA 076220 | — | Sep 02, 2003 | |
| OFLOXACIN×3 | TEVA | ANDA 076182 | AB | Sep 02, 2003 | |
| OFLOXACIN | BEDFORD | ANDA 075762 | — | Jan 16, 2002 |
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.
Ofloxacin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
