Drug application
ZADITOR (KETOTIFEN FUMARATE)
Drugs@FDA ANDA 077200 · ALCON PHARMS LTD
Key facts
| Drug name | ZADITOR |
|---|---|
| Active ingredients | KETOTIFEN FUMARATE |
| Application type | ANDA |
| Application number | 077200 |
| Company | ALCON PHARMS LTD |
| Dosage forms | SOLUTION/DROPS, OPHTHALMIC |
| Strength | EQ 0.025% BASE |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Sep 2, 2008 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: