Cuvposa
These highlights do not include all the information needed to use CUVPOSA safely and effectively. See full prescribing information for CUVPOSA. CUVPOSA (glycopyrrolate) oral solution Initial U.S. Approval: 1961
Approved
Approval ID
d200bd44-9856-4104-a29e-a4cca3db6737
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2023
Manufacturers
FDA
Merz Pharmaceuticals, LLC
DUNS: 126209282
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0259-0501
Application NumberNDA022571
Product Classification
M
Marketing Category
C73594
G
Generic Name
glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (10)
SorbitolInactive
Code: 506T60A25R
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
glycopyrrolateActive
Quantity: 1 mg in 5 mL
Code: V92SO9WP2I
Classification: ACTIB
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Sodium Citrate, Unspecified FormInactive
Code: 1Q73Q2JULR
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT