Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
Unknown Title
Approved
Approval ID
88015023-2955-4797-baa4-fa104e80cb62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2012
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.
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-030
Application NumberANDA079247
Product Classification
M
Marketing Category
C73584
G
Generic Name
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification
INGREDIENTS (4)
SODIUM PHOSPHATE, DIBASIC ANHYDROUSActive
Quantity: 0.398 g in 1 1
Code: 22ADO53M6F
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 1.105 g in 1 1
Code: 593YOG76RN
Classification: ACTIB