FDA.reportPublic FDA data

Application 210653

Type
ANDA
Sponsor
TULEX PHARMS INC

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
10135-698clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-698clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-699clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-699clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-700clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-700clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
52817-280Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-280Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-280Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-281Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-281Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-281Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-282Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-282Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-282Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent