FDA.reportPublic FDA data

Application 203981

Type
ANDA
Sponsor
CALL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADAPALENEADAPALENESOLUTION;TOPICAL0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
28595-530AdapaleneADAPALENEAllegis Pharmaceuticals, LLCANDACurrent
49908-117Adapalene Topical SolutionAdapalene Topical SolutionCALL INC (d.b.a Rochester Pharmaceuticals)ANDACurrent
49908-117Adapalene Topical SolutionAdapalene Topical SolutionCALL INC (d.b.a Rochester Pharmaceuticals)ANDACurrent
49908-117Adapalene Topical SolutionAdapalene Topical SolutionCALL INC (d.b.a Rochester Pharmaceuticals)ANDACurrent
71297-410Adapalene Topical SolutionAdapalene Topical SolutionAllegis Holdings LLCANDACurrent
71297-410Adapalene Topical SolutionAdapalene Topical SolutionAllegis Holdings LLCANDACurrent
71297-410Adapalene Topical SolutionAdapalene Topical SolutionAllegis Holdings LLCANDACurrent