FDA.reportPublic FDA data

Application 215420

Type
ANDA
Sponsor
ANNORA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPOWDER;ORAL100MG/PACKETNoNo
002SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDEPOWDER;ORAL500MG/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-047Sapropterin dihydrochlorideSapropterin dihydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-048Sapropterin dihydrochlorideSapropterin dihydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent