NDC 82111-518
DARTISLA ODT
Glycopyrrolate Orally Disintegrating Tablets
DARTISLA ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Edenbridge Pharmaceuticals Llc.. The primary component is Glycopyrrolate.
| Product ID | 82111-518_b7fa57f9-9e30-4011-8e80-d2e5699d5b6a |
| NDC | 82111-518 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DARTISLA ODT |
| Generic Name | Glycopyrrolate Orally Disintegrating Tablets |
| Dosage Form | Tablet, Orally Disintegrating |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-02-01 |
| Marketing Category | NDA / |
| Application Number | NDA215019 |
| Labeler Name | Edenbridge Pharmaceuticals LLC. |
| Substance Name | GLYCOPYRROLATE |
| Active Ingredient Strength | 2 mg/1 |
| Pharm Classes | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 82111-518-01
3 BLISTER PACK in 1 CARTON (82111-518-01) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
| Marketing Start Date | 2022-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
Trademark Results [DARTISLA ODT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DARTISLA ODT 90877449 not registered Live/Pending |
Edenbridge Pharmaceuticals, LLC 2021-08-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.