Orange Book product · Generic (ANDA)
MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE
At a glance
Mar 02, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 02, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
MOXIFLOXACIN HYDROCHLORIDE
Strength
EQ 400MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209143
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MOXIFLOXACIN HYDROCHLORIDE
- 2015MOXIFLOXACIN HYDROCHLORIDEBrand (NDA)
NDA 205572 · FRESENIUS KABI USA
- 2010MOXEZABrand (NDA)
NDA 022428 · HARROW EYE
- 2003VIGAMOXBrand (NDA)
NDA 021598 · HARROW EYE
- 2001AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERBrand (NDA)
NDA 021277 · BAYER HLTHCARE
- 1999AVELOXBrand (NDA)
NDA 021085 · BAYER HLTHCARE
- 2025MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 219475 · FDC LTD
- 2025MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217988 · MANKIND PHARMA
- 2024MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 209698 · SOMERSET THERAPS LLC
- 2023MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 204836 · HETERO LABS LTD V
- 2021MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 212616 · UPSHER SMITH LABS
- 2020MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208778 · GLAND
- 2020MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 206447 · PHARMOBEDIENT
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.
