GaviLyte G
These highlights do not include all the information needed to use GaviLyte™ G safely and effectively. See full prescribing information for GaviLyte™ G. GaviLyte™ G (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) Initial U.S. Approval:1984
Approved
Approval ID
4b5254c5-4a61-4711-92b4-acc8e3137904
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2016
Manufacturers
FDA
Lupin Pharmaceuticals,Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
polyethylene glycol-3350 and Electrolytes
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43386-090
Application NumberANDA090231
Product Classification
M
Marketing Category
C73584
G
Generic Name
polyethylene glycol-3350 and Electrolytes
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2016
FDA Product Classification
INGREDIENTS (7)
SODIUM BICARBONATEActive
Quantity: 6.74 g in 274.31 g
Code: 8MDF5V39QO
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 5.86 g in 274.31 g
Code: 451W47IQ8X
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 274.31 g
Code: 36KCS0R750
Classification: ACTIR
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 274.31 g
Code: 660YQ98I10
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 274.31 g
Code: G2M7P15E5P
Classification: ACTIB