SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
These highlights do not include all the information needed to use SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID FOR ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID FOR ORAL SOLUTION. SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID for oral solution Initial U.S. Approval: 2012
Approved
Approval ID
b759dc12-2dc1-4ef4-a375-1a61630d54d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2022
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-874
Application NumberANDA212789
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2022
FDA Product Classification
INGREDIENTS (8)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
MAGNESIUM OXIDEActive
Quantity: 3.5 g in 16.1 g
Code: 3A3U0GI71G
Classification: ACTIM
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
SODIUM PICOSULFATEActive
Quantity: 10 mg in 16.1 g
Code: LR57574HN8
Classification: ACTIB
ANHYDROUS CITRIC ACIDActive
Quantity: 12 g in 16.1 g
Code: XF417D3PSL
Classification: ACTIB