Orange Book product · Generic (ANDA)
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
MOXIFLOXACIN HYDROCHLORIDE
At a glance
May 05, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 05, 2017
9 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
MOXIFLOXACIN HYDROCHLORIDE
Strength
400MG/250ML (1.6MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 205833
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 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
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.
