Drug application
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
Drugs@FDA ANDA 213264 · TP ANDA HOLDINGS
Key facts
| Drug name | FLUOCINOLONE ACETONIDE |
|---|---|
| Active ingredients | FLUOCINOLONE ACETONIDE |
| Application type | ANDA |
| Application number | 213264 |
| Company | TP ANDA HOLDINGS |
| Dosage forms | OIL/DROPS, OTIC |
| Strength | 0.01% |
| Marketing status | Prescription |
| TE codes | AT |
| Reference listed drug | No |
| Latest submission status date | Feb 5, 2021 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 10–99 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.