moxifloxacin hydrochloride

FDA Drug Profile — MOXIFLOXACIN HYDROCHLORIDE, Moxifloxacin, VIGAMOX, Moxifloxacin Ophthalmic Solution

moxifloxacin hydrochloride is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including MOXIFLOXACIN HYDROCHLORIDE, Moxifloxacin, VIGAMOX. Available dosage forms: tablet, film coated, powder, solution/ drops.

Drug Details

Generic Name
moxifloxacin hydrochloride
Brand Names
MOXIFLOXACIN HYDROCHLORIDE, Moxifloxacin, VIGAMOX, Moxifloxacin Ophthalmic Solution
Application Number
ANDA202632
Sponsor
PD-Rx Pharmaceuticals, Inc.
NDC Codes
11
Dosage Forms
TABLET, FILM COATED, POWDER, SOLUTION/ DROPS
Routes
ORAL, 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 influenza 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. ( 1 )