| Active ingredient (INN) | Diphenoxylate Hydrochloride And Atropine Sulfate |
|---|---|
| Therapeutic category |
| Auto-created by FDA Drug Enforcement — Full Recall Database scraper |
| Controlled substance | No |
|---|
| Marketing-authorisation holders | HIKMA PHARMACEUTICALS USA INC., SpecGx LLC |
|---|
| Registrations on file | 2 |
|---|
| Patient information leaflet (PIL) | Not on file |
|---|
| Summary of product characteristics (SPC) | Not on file |
|---|
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| Diphenoxylate Hydrochloride and Atropine Sulfate | .025; 2.5mg/5mL; mg/5mL | solution | 🇺🇸 US | HIKMA PHARMACEUTICALS USA INC. | Active |
| Diphenoxylate Hydrochloride and Atropine Sulfate | .025; 2.5mg/1; mg/1 | tablet | 🇺🇸 US | SpecGx LLC | Active |