FDA.reportPublic FDA data

Application 200480

Type
ANDA
Sponsor
NOVOCOL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYCLOPRODYCLONINE HYDROCHLORIDESOLUTION;TOPICAL0.5%NoYes
002DYCLOPRODYCLONINE HYDROCHLORIDESOLUTION;TOPICAL1%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0362-3918DycloProDyclonine HydrochlorideSeptodont IncANDACurrent
0362-3971DycloProDyclonine HydrochlorideSeptodont IncANDACurrent
0362-3971DycloProDyclonine HydrochlorideSeptodont IncANDACurrent
0362-3971DycloProDyclonine HydrochlorideSeptodont IncANDACurrent