gatifloxacin

FDA Drug Profile — Gatifloxacin, ZYMAXID

gatifloxacin is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Gatifloxacin, ZYMAXID. Available dosage form: solution/ drops.

Drug Details

Generic Name
gatifloxacin
Brand Names
Gatifloxacin, ZYMAXID
Application Number
ANDA204227
Sponsor
Sandoz Inc
NDC Codes
3
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
GATIFLOXACIN

Indications and Usage

1 INDICATIONS & USAGE Gatifloxacin ophthalmic solution 0.5 % is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group* Streptococcus oralis* Streptococcus pneumoniae Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution 0.5 % is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae