Drug application
KETOTIFEN FUMARATE (KETOTIFEN FUMARATE)
Drugs@FDA ANDA 204059 · UNICHEM
Key facts
| Drug name | KETOTIFEN FUMARATE |
|---|---|
| Active ingredients | KETOTIFEN FUMARATE |
| Application type | ANDA |
| Application number | 204059 |
| Company | UNICHEM |
| Dosage forms | SOLUTION/DROPS, OPHTHALMIC |
| Strength | EQ 0.025% BASE |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Jun 1, 2020 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
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.