Moxifloxacin ophthalmic solution

FDA Drug Profile — Moxifloxacin ophthalmic solution

Drug Details

Generic Name
Moxifloxacin ophthalmic solution
Brand Names
Moxifloxacin ophthalmic solution
Application Number
ANDA209469
Sponsor
Alembic Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
MOXIFLOXACIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. MOXIFLOXACIN ophthalmic solution is a topical fluoroquinolone anti- infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis , Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii* , Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.