GaviLyte - C
GaviLyte™-C with Flavor Pack(PEG-3350 (240 g) and Electrolytes for Oral Solution, USP) with flavor pack
Approved
Approval ID
a8b15625-ca7c-4d57-9f36-3ac2a6d13665
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2017
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 with Flavor Pack
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43386-060
Application NumberANDA090186
Product Classification
M
Marketing Category
C73584
G
Generic Name
polyethylene glycol-3350 and electrolytes with Flavor Pack
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2017
FDA Product Classification
INGREDIENTS (7)
POTASSIUM CHLORIDEActive
Quantity: 2.98 g in 278.26 g
Code: 660YQ98I10
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.84 g in 278.26 g
Code: 451W47IQ8X
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.72 g in 278.26 g
Code: 8MDF5V39QO
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Active
Quantity: 240 g in 278.26 g
Code: G2M7P15E5P
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.72 g in 278.26 g
Code: 36KCS0R750
Classification: ACTIR
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT