FDA.reportPublic FDA data

Application 211676

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCARNITINELEVOCARNITINESOLUTION;ORAL1GM/10MLNoNo
002LEVOCARNITINE SFLEVOCARNITINESOLUTION;ORAL1GM/10MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70954-139LevocarnitineLevocarnitine Oral SolutionNovitium Pharma LLCANDACurrent
70954-139LevocarnitineLevocarnitine Oral SolutionNovitium Pharma LLCANDACurrent
70954-139LevocarnitineLevocarnitine Oral SolutionNovitium Pharma LLCANDACurrent
70954-140LevocarnitineLevocarnitine Oral Solution (Suguar Free) 1 g/10 mLNovitium Pharma LLCANDACurrent
70954-140LevocarnitineLevocarnitine Oral Solution (Suguar Free) 1 g/10 mLNovitium Pharma LLCANDACurrent
70954-140LevocarnitineLevocarnitine Oral Solution (Suguar Free) 1 g/10 mLNovitium Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60210ORIG2019-10-03