FDA.reportPublic FDA data

Application 203775

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDECAPSULE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-657Cevimeline HydrochlorideCevimeline HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
16571-657Cevimeline HydrochlorideCevimeline HydrochlorideRising Pharma Holdings, Inc.ANDACurrent