Drug application
PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
Drugs@FDA ANDA 212778 · UPSHER SMITH LABS
Key facts
| Drug name | PREDNISOLONE ACETATE |
|---|---|
| Active ingredients | PREDNISOLONE ACETATE |
| Application type | ANDA |
| Application number | 212778 |
| Company | UPSHER SMITH LABS |
| Dosage forms | SUSPENSION/DROPS, OPHTHALMIC |
| Strength | 1% |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Sep 28, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 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.