FDA — authorised 30 November 2001
- Application: NDA021277
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 MOXIFLOXACIN HYDROCHLORIDE in United States
FDA authorised MOXIFLOXACIN HYDROCHLORIDE on 30 November 2001 · 8,447 US adverse-event reports
Marketing authorisations
FDA — authorised 18 February 2014
- Application: ANDA077437
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2014
- Application: ANDA202632
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2014
- Application: ANDA076938
- Marketing authorisation holder: DR REDDYS
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2014
- Application: ANDA200160
- Marketing authorisation holder: TORRENT
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2014
- Application: ANDA202867
- Marketing authorisation holder: LUPIN
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 6 March 2015
- Application: ANDA202525
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 April 2015
- Application: NDA205572
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 28 May 2015
- Application: ANDA204079
- Marketing authorisation holder: LUPIN
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 January 2016
- Application: ANDA205348
- Marketing authorisation holder: CROSSMEDIKA SA
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2017
- Application: ANDA207285
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2017
- Application: ANDA205833
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 22 September 2017
- Application: ANDA208682
- Marketing authorisation holder: MSN
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 October 2017
- Application: ANDA206242
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 November 2017
- Application: ANDA202916
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 September 2018
- Application: ANDA206295
- Marketing authorisation holder: SUNSHINE
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2019
- Application: ANDA209469
- Marketing authorisation holder: ALEMBIC
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 March 2020
- Application: ANDA206447
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 March 2020
- Application: ANDA208778
- Marketing authorisation holder: GLAND
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 February 2021
- Application: ANDA212616
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA204836
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2024
- Application: ANDA209698
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 27 January 2025
- Application: ANDA217988
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 August 2025
- Application: ANDA219475
- Marketing authorisation holder: FDC LTD
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 2 March 2026
- Application: ANDA209143
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078073
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: MOXIFLOXACIN HYDROCHLORIDE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 8,447
Most-reported reactions
- Asthma — 1,130 reports (13.38%)
- Drug Hypersensitivity — 957 reports (11.33%)
- Dyspnoea — 884 reports (10.47%)
- Pain — 852 reports (10.09%)
- Wheezing — 841 reports (9.96%)
- Off Label Use — 820 reports (9.71%)
- Rash — 812 reports (9.61%)
- Pneumonia — 781 reports (9.25%)
- Vomiting — 695 reports (8.23%)
- Drug Ineffective — 675 reports (7.99%)
MOXIFLOXACIN HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is MOXIFLOXACIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 30 November 2001; FDA authorised it on 18 February 2014; FDA authorised it on 4 March 2014.
Who is the marketing authorisation holder for MOXIFLOXACIN HYDROCHLORIDE in United States?
BAYER HLTHCARE holds the US marketing authorisation.