| NDC Code | 54766-200-10 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (54766-200-10) |
|---|
| Product NDC | 54766-200 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Motofen |
|---|
| Non-Proprietary Name | Difenoxin And Atropine Sulfate |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20170411 |
|---|
| End Marketing Date | 20280831 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA017744 |
|---|
| Manufacturer | Sebela Pharmaceuticals Inc. |
|---|
| Substance Name | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE |
|---|
| Strength | .025; 1 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
|---|
| DEA Schedule | CIV |
|---|