FDA.reportPublic FDA data

Application 215798

Type
ANDA
Sponsor
DR REDDYS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-162Sapropterin DihydrochlorideSapropterin DihydrochlorideDr. Reddys Laboratories IncANDACurrent
43598-162JAVYGTORSapropterin DihydrochlorideDr. Reddys Laboratories IncANDACurrent