FDA.reportPublic FDA data

Application 213729

Type
ANDA
Sponsor
NOVITIUM PHARMA

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
70954-120Carglumic AcidCarglumic AcidNovitium Pharma LLCANDACurrent
71863-114Carglumic AcidCarglumic AcidEton Pharmaceuticals, Inc.ANDACurrent
71863-114Carglumic AcidCarglumic AcidEton Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69690ORIG2021-12-20