KRISTALOSE
KRISTALOSE (lactulose) For Oral SolutionCumberland Pharmaceuticals Inc.
Approved
Approval ID
535dd1ea-b567-49f7-9a84-8ea91e78c466
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2018
Manufacturers
FDA
Cumberland Pharmaceuticals Inc.
DUNS: 069532880
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lactulose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66220-729
Application NumberANDA074712
Product Classification
M
Marketing Category
C73584
G
Generic Name
lactulose
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2022
FDA Product Classification
INGREDIENTS (1)
lactuloseActive
Quantity: 20 g in 20 g
Code: 9U7D5QH5AE
Classification: ACTIB
lactulose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66220-719
Application NumberANDA074712
Product Classification
M
Marketing Category
C73584
G
Generic Name
lactulose
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2022
FDA Product Classification
INGREDIENTS (1)
lactuloseActive
Quantity: 10 g in 10 g
Code: 9U7D5QH5AE
Classification: ACTIB