Orange Book product · Brand (NDA)
MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE
At a glance
Apr 03, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 03, 2015
11 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MOXIFLOXACIN HYDROCHLORIDE
Strength
EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 205572
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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
- 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.
