DARTISLA ODT
These highlights do not include all the information needed to use DARTISLA ODT safely and effectively. See full prescribing information for DARTISLA ODT. DARTISLA ODT (glycopyrrolate) Orally Disintegrating Tablets Initial U.S. Approval: 1961
Approved
Approval ID
52daf47e-7ba3-4105-be7f-27001a87e16e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
Edenbridge Pharmaceuticals LLC.
DUNS: 948715060
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glycopyrrolate Orally Disintegrating Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82111-517
Application NumberNDA215019
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glycopyrrolate Orally Disintegrating Tablets
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (1)
GLYCOPYRROLATEActive
Quantity: 0.85 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
Glycopyrrolate Orally Disintegrating Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82111-518
Application NumberNDA215019
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glycopyrrolate Orally Disintegrating Tablets
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (1)
GLYCOPYRROLATEActive
Quantity: 1.7 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB