FDA.reportPublic FDA data

Application 213897

Type
ANDA
Sponsor
AJANTA PHARMA 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
27241-210Clomipramine hydrochlorideClomipramine hydrochlorideAjanta Pharma LimitedANDACurrent
27241-210Clomipramine hydrochlorideClomipramine hydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-211Clomipramine hydrochlorideClomipramine hydrochlorideAjanta Pharma LimitedANDACurrent
27241-211Clomipramine hydrochlorideClomipramine hydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-212Clomipramine hydrochlorideClomipramine hydrochlorideAjanta Pharma LimitedANDACurrent
27241-212Clomipramine hydrochlorideClomipramine hydrochlorideAjanta Pharma USA Inc.ANDACurrent