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Polyethylene Glycol 3350 and electrolytes - Unflavored

These highlights do not include all the information needed to use POLYETHYLENE GLYCOL 3350 and ELECTROLYTES FOR ORAL SOLUTION safely and effectively. See full prescribing information for POLYETHYLENE GLYCOL 3350 and ELECTROLYTES FOR ORAL SOLUTION. POLYETHYLENE GLYCOL 3350 and ELECTROLYTES for oral solution. Initial U.S. Approval: 1984

Approved
Approval ID

48c741a9-9039-4fdb-a875-86d4ea968282

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 9, 2022

Manufacturers
FDA

Strides Pharma Science Limited

DUNS: 650738743

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Polyethylene Glycol 3350 and electrolytes - Unflavored

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64380-765
Application NumberANDA204558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polyethylene Glycol 3350 and electrolytes - Unflavored
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification

INGREDIENTS (5)

POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.74 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 4 L
Code: 36KCS0R750
Classification: ACTIR
SODIUM CHLORIDEActive
Quantity: 5.86 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORATEActive
Quantity: 2.97 g in 4 L
Code: H35KS68EE7
Classification: ACTIB

Polyethylene Glycol 3350 and electrolytes with Orange Flavor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64380-767
Application NumberANDA204558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polyethylene Glycol 3350 and electrolytes with Orange Flavor
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification

INGREDIENTS (5)

POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 4 L
Code: 36KCS0R750
Classification: ACTIR
SODIUM BICARBONATEActive
Quantity: 6.74 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 4 L
Code: 660YQ98I10
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.86 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB

Polyethylene Glycol 3350 and electrolytes with Lemon Flavor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64380-766
Application NumberANDA204558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polyethylene Glycol 3350 and electrolytes with Lemon Flavor
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification

INGREDIENTS (5)

POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 4 L
Code: G2M7P15E5P
Classification: ACTIB
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 4 L
Code: 36KCS0R750
Classification: ACTIR
SODIUM BICARBONATEActive
Quantity: 6.74 g in 4 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.86 g in 4 L
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 4 L
Code: 660YQ98I10
Classification: ACTIB

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