Application 017744
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MOTOFEN HALF-STRENGTH | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE | TABLET;ORAL | 0.025MG;0.5MG | No | No |
| 002 | MOTOFEN | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE | TABLET;ORAL | 0.025MG;1MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54766-200 | Motofen | difenoxin and atropine sulfate | Sebela Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47747 | SUPPL | 2017-03-29 |
| 47746 | SUPPL | 2017-03-29 |