Details for New Drug Application (NDA): 215019
✉ Email this page to a colleague
NDA 215019 describes DARTISLA ODT, which is a drug marketed by Edenbridge Pharms and is included in one NDA. Additional details are available on the DARTISLA ODT profile page.
The generic ingredient in DARTISLA ODT is glycopyrrolate. There are seventeen drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
The generic ingredient in DARTISLA ODT is glycopyrrolate. There are seventeen drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 215019
| Tradename: | DARTISLA ODT |
| Applicant: | Edenbridge Pharms |
| Ingredient: | glycopyrrolate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215019
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1.7MG | ||||
| Approval Date: | Dec 16, 2021 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.85MG | ||||
| Approval Date: | Oct 11, 2023 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
