Details for New Drug Application (NDA): 215019
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NDA 215019 describes DARTISLA ODT, which is a drug marketed by Edenbridge Pharms and is included in one NDA. It is available from one supplier. 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. Fifty-six 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. Fifty-six 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 |
Pharmacology for NDA: 215019
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 215019
Suppliers and Packaging for NDA: 215019
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARTISLA ODT | glycopyrrolate | TABLET, ORALLY DISINTEGRATING;ORAL | 215019 | NDA | Edenbridge Pharmaceuticals LLC. | 82111-517 | 82111-517-01 | 3 BLISTER PACK in 1 CARTON (82111-517-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
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 | |||||
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