Orange Book product · Brand (NDA)
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
MOXIFLOXACIN HYDROCHLORIDE
At a glance
Nov 30, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 2001
24 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MOXIFLOXACIN HYDROCHLORIDE
Strength
400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 021277
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2015MOXIFLOXACIN HYDROCHLORIDEBrand (NDA)
NDA 205572 · FRESENIUS KABI USA
- 2010MOXEZABrand (NDA)
NDA 022428 · HARROW EYE
- 2003VIGAMOXBrand (NDA)
NDA 021598 · HARROW EYE
- 1999AVELOXBrand (NDA)
NDA 021085 · BAYER HLTHCARE
- 2026MOXIFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 209143 · MACLEODS PHARMS LTD
- 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.
