Application 215019
- Type
- NDA
- Sponsor
- EDENBRIDGE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DARTISLA ODT | GLYCOPYRROLATE | TABLET;ORALLY DISINTEGRATING | 1.7MG | No | No |
| 002 | DARTISLA ODT | GLYCOPYRROLATE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.85MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 82111-518 | DARTISLA ODT | Glycopyrrolate Orally Disintegrating Tablets | Edenbridge Pharmaceuticals LLC. | NDA | Current |