FdaApplication
NDA 215019
Identifiers
- fda_app_no: NDA215019
Properties
| Property | Value |
|---|---|
| applicant_name | EDENBRIDGE PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 2021-12-16 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DARTISLA ODT | GLYCOPYRROLATE | 1.7MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| DARTISLA ODT | GLYCOPYRROLATE | 0.85MG | TABLET, ORALLY DISINTEGRATING;ORAL |
2 products