FDA.reportPublic FDA data

Application 209294

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo
002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL50MGNoNo
003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-492Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-492Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-492Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-492Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-492Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-493Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-493Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-493Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-493Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-493Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-494Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-494Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-494Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-494Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent
68180-494Clomipramine HydrochlorideClomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.ANDACurrent