FDA Orange Book · active-ingredient family
Moxifloxacin hydrochloride
Moxifloxacin hydrochloride is approved as 5 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MOXIFLOXACIN HYDROCHLORIDE · NDA 205572
5
Brand (NDA)
25
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, solution/drops, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDERLD | FRESENIUS KABI USA | NDA 205572 | — | Apr 03, 2015 | |
| MOXEZARLD | HARROW EYE | NDA 022428 | — | Nov 19, 2010 | |
| VIGAMOXRLD | HARROW EYE | NDA 021598 | AT1 | Apr 15, 2003 | |
| AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERRLD | BAYER HLTHCARE | NDA 021277 | — | Nov 30, 2001 | |
| AVELOXRLD | BAYER HLTHCARE | NDA 021085 | — | Dec 10, 1999 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE | MACLEODS PHARMS LTD | ANDA 209143 | AB | Mar 02, 2026 | |
| MOXIFLOXACIN HYDROCHLORIDE | FDC LTD | ANDA 219475 | — | Aug 04, 2025 | |
| MOXIFLOXACIN HYDROCHLORIDE | MANKIND PHARMA | ANDA 217988 | AT1 | Jan 27, 2025 | |
| MOXIFLOXACIN HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 209698 | AT1 | Nov 14, 2024 | |
| MOXIFLOXACIN HYDROCHLORIDE | HETERO LABS LTD V | ANDA 204836 | AB | Mar 02, 2023 | |
| MOXIFLOXACIN HYDROCHLORIDE | UPSHER SMITH LABS | ANDA 212616 | AT1 | Feb 10, 2021 | |
| MOXIFLOXACIN HYDROCHLORIDE | GLAND | ANDA 208778 | AT1 | Mar 30, 2020 | |
| MOXIFLOXACIN HYDROCHLORIDE | PHARMOBEDIENT | ANDA 206447 | — | Mar 30, 2020 | |
| MOXIFLOXACIN HYDROCHLORIDE | ALEMBIC | ANDA 209469 | AT1 | Feb 13, 2019 | |
| MOXIFLOXACIN HYDROCHLORIDE | SUNSHINE | ANDA 206295 | AB | Sep 28, 2018 | |
| MOXIFLOXACIN HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 202916 | — | Nov 09, 2017 | |
| MOXIFLOXACIN HYDROCHLORIDE | EUGIA PHARMA | ANDA 206242 | AT1 | Oct 04, 2017 | |
| MOXIFLOXACIN HYDROCHLORIDE | MSN | ANDA 208682 | AB | Sep 22, 2017 | |
| MOXIFLOXACIN HYDROCHLORIDE | APOTEX | ANDA 090080 | AT1 | Jun 30, 2017 | |
| MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | MYLAN LABS LTD | ANDA 205833 | — | May 05, 2017 | |
| MOXIFLOXACIN HYDROCHLORIDE | CHARTWELL RX | ANDA 207285 | AB | Feb 13, 2017 | |
| MOXIFLOXACIN HYDROCHLORIDE | CROSSMEDIKA SA | ANDA 205348 | AB | Jan 14, 2016 | |
| MOXIFLOXACIN HYDROCHLORIDE | NATCO | ANDA 204635 | — | Aug 31, 2015 | |
| MOXIFLOXACIN HYDROCHLORIDE | LUPIN | ANDA 204079 | — | May 28, 2015 | |
| MOXIFLOXACIN HYDROCHLORIDE | REGCON HOLDINGS | ANDA 202525 | AT1 | Mar 06, 2015 | |
| MOXIFLOXACIN HYDROCHLORIDE | LUPIN | ANDA 202867 | AT1 | Sep 04, 2014 | |
| MOXIFLOXACIN HYDROCHLORIDE | TORRENT | ANDA 200160 | — | Apr 03, 2014 | |
| MOXIFLOXACIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 202632 | AB | Mar 04, 2014 | |
| MOXIFLOXACIN HYDROCHLORIDE | DR REDDYS | ANDA 076938 | AB | Mar 04, 2014 | |
| MOXIFLOXACIN HYDROCHLORIDE | TEVA PHARMS USA | ANDA 077437 | AB | Feb 18, 2014 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9114168 | May 29, 2029 | in 3 yr | Product |
| 8450311 | May 29, 2029 | in 3 yr | Product |
Moxifloxacin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
