FDA.reportPublic FDA data

Application 090453

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDETABLET;ORAL25MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-336Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-336Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-337Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-337Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-338Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent
42806-338Molindone HydrochlorideMolindone HydrochlorideEPIC PHARMA, LLCANDACurrent