FDA.reportPublic FDA data

Application 074364

Type
ANDA
Sponsor
SANDOZ

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
0781-2027Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2027Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2027Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2027Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2037Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2037Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2037Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2037Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent
0781-2047Clomipramine HydrochlorideClomipramine HydrochlorideSandoz IncANDACurrent