FDA.reportPublic FDA data

Application 211822

Type
ANDA
Sponsor
ALEMBIC PHARMS 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
46708-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
62332-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-407CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-408CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-409CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent