Lactulose
Lactulose Solution, USP
Approved
Approval ID
e9734719-07b9-4ac9-b082-be07f4e9a68f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2018
Manufacturers
FDA
Bio-Pharm, Inc.
DUNS: 801652546
Products 1
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 Code59741-249
Application NumberANDA207786
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lactulose
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2018
FDA Product Classification
INGREDIENTS (1)
LACTULOSEActive
Quantity: 10 g in 15 mL
Code: 9U7D5QH5AE
Classification: ACTIB