NDA 21598, held by Harrow Eye. Moxifloxacin Hydrochloride.
As of Nov 14, 2026, NDA 21598 (Vigamox), held by Harrow Eye, was first approved by FDA on Apr 15, 2003, with 8 approved supplements and 0 published complete response letters.
VIGAMOX 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VigamoxEQ 0.5% BASE · solution/drops;ophthalmic | Moxifloxacin Hydrochloride | RxReference drug |
| Jun 2, 2020 | Supplement 24Labeling · Standard review | Approved | |
| May 11, 2020 | Supplement 23Labeling · Standard review | Approved | |
| Mar 14, 2017 | Supplement 22Labeling · Standard review | Approved | |
| Oct 7, 2011 | Supplement 17Labeling | Approved | |
| Jun 25, 2004 | Supplement 8Labeling · Standard review | Approved | |
| Apr 12, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Oct 3, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Oct 3, 2003 | Supplement 1Manufacturing · Standard review | Approved | |
| Apr 15, 2003 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
