FDA.reportPublic FDA data

Application 076645

Type
ANDA
Sponsor
BAJAJ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACTULOSELACTULOSESOLUTION;ORAL, RECTAL10GM/15MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61037-471Lactulose SolutionLactulose Solution USP, 10 g/15 mLBajaj Medical, LLCANDACurrent
61037-471Lactulose SolutionLactulose Solution USP, 10 g/15 mLBajaj Medical, LLCANDACurrent