Generlac
GENERLAC SOLUTION10 g/15 mL(Lactulose Solution, USP) For Oral or Rectal Administration Rx only
Approved
Approval ID
2a2eee86-273e-4718-8f78-34f15e193040
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2019
Manufacturers
FDA
Morton Grove Pharmaceuticals, Inc.
DUNS: 801897505
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 Code60432-038
Application NumberANDA074603
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lactulose
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateJanuary 8, 2019
FDA Product Classification
INGREDIENTS (1)
LACTULOSEActive
Quantity: 10 g in 15 mL
Code: 9U7D5QH5AE
Classification: ACTIB