Application 208003

Type
ANDA
Sponsor
PRINSTON PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDECAPSULE;ORALEQ 0.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-003FINGOLIMODfingolimodSolco Healthcare US, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50335ORIG2017-11-08