Polyethylene Glycol-3350 and Electrolytes with Flavor Pack
PEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack
Approved
Approval ID
bf8925e7-6ea6-448c-810d-6f0d99127896
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2009
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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
NDC Product Code40032-060
Application NumberANDA090186
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 18, 2009
Generic NamePolyethylene Glycol-3350 and Electrolytes with Flavor Pack
INGREDIENTS (9)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
POLYETHYLENE GLYCOL 3350Active
Quantity: 240 g in 278.26 g
Code: G2M7P15E5P
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.72 g in 278.26 g
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.84 g in 278.26 g
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.98 g in 278.26 g
Code: 660YQ98I10
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.72 g in 278.26 g
Code: 36KCS0R750
Classification: ACTIB
ALPHA-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT