FDA.reportPublic FDA data

Application 211364

Type
ANDA
Sponsor
LEADING PHARMA LLC

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
69315-165Clomipramine HydrochlorideClomipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-166Clomipramine HydrochlorideClomipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-167Clomipramine HydrochlorideClomipramine HydrochlorideLeading Pharma, LLCANDACurrent
71205-910Clomipramine HydrochlorideClomipramine HydrochlorideProficient Rx LPANDACurrent
71205-910Clomipramine HydrochlorideClomipramine HydrochlorideProficient Rx LPANDACurrent
71205-911Clomipramine HydrochlorideClomipramine HydrochlorideProficient Rx LPANDACurrent
71205-911Clomipramine HydrochlorideClomipramine HydrochlorideProficient Rx LPANDACurrent
71205-912Clomipramine HydrochlorideClomipramine HydrochlorideProficient Rx LPANDACurrent
71205-912Clomipramine HydrochlorideClomipramine HydrochlorideProficient Rx LPANDACurrent