Glycopyrrolate Oral Solution
Glycopyrrolate Oral Solution 1 mg/5 mL
Approved
Approval ID
78ff2314-3a87-8554-e053-2991aa0a33ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Suven Pharmaceuticals Limited
DUNS: 677604288
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glycopyrrolate Oral Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68022-0156
Application NumberANDA212467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate Oral Solution
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (1)
GLYCOPYRROLATEActive
Quantity: 1 mg in 5 mL
Code: V92SO9WP2I
Classification: ACTIB