FDA.reportPublic FDA data

Application 204746

Type
ANDA
Sponsor
NOVEL LABS INC

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
40032-999cevimeline hydrochloridecevimeline hydrochlorideNovel Laboratories, Inc.ANDACurrent
43386-999cevimeline hydrochloridecevimeline hydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent