FDA.reportPublic FDA data

Application 213395

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARGLUMIC ACIDCARGLUMIC ACIDTABLET, FOR SUSPENSION;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-459Carglumic acidCarglumic acidBurel Pharmaceuticals, LLCANDACurrent
68475-006Carglumic acidCarglumic acidNavinta LLCANDACurrent