FDA.reportPublic FDA data

Application 074953

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
0832-0630Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0832-0630Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0630Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0631Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0832-0631Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0631Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0632Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0832-0632Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-0632Clomipramine HydrochlorideClomipramine HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent