Drug application
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
Drugs@FDA ANDA 220100 · BIONPHARMA
Key facts
| Drug name | LOPERAMIDE HYDROCHLORIDE |
|---|---|
| Active ingredients | LOPERAMIDE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 220100 |
| Company | BIONPHARMA |
| Dosage forms | SOLUTION, ORAL |
| Strength | 1MG/7.5ML |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Sep 19, 2025 |
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.