Active ingredient
Gatifloxacin
4 finished FDA listings contain Gatifloxacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GATIFLOXACIN, GATIFLOXACIN ANHYDROUS, GATIFLOXACIN HEMIHYDRATE
- Dosage forms
- Solution, Solution/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 4
- Strengths listed
- 5 mg/ml
- Brand names in FDA listings
- Zymaxid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 228476
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022548 | ABBVIE | 2010-05-18 | 1 |
| ANDA 204227 | SANDOZ | 2016-07-11 | 1 |
| ANDA 213542 | CAPLIN | 2021-11-03 | 2 |
Official labeling on DailyMed
- GATIFLOXACIN SOLUTION/ DROPS [SANDOZ INC] · version 15 · 2026-09-04
- ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] · version 12 · 2026-08-07
- GATIFLOXACIN OPHTHALMIC SOLUTION 0.5% SOLUTION [CAPLIN STERILES LIMITED] · version 1 · 2025-11-17
- GATIFLOXACIN SOLUTION [LEADING PHARMA, LLC] · version 2 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.