FDA.reportPublic FDA data

Application 074947

Type
ANDA
Sponsor
MYLAN

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
0378-3025Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3025Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3025Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3050Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3050Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3050Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3075Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3075Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3075Clomipramine Hydrochlorideclomipramine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
43063-257Clomipramine Hydrochlorideclomipramine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-257Clomipramine Hydrochlorideclomipramine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-257Clomipramine Hydrochlorideclomipramine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-257Clomipramine Hydrochlorideclomipramine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
51407-315Clomipramine Hydrochlorideclomipramine hydrochlorideGolden State Medical SupplyANDACurrent
51407-316Clomipramine Hydrochlorideclomipramine hydrochlorideGolden State Medical SupplyANDACurrent
51407-317Clomipramine Hydrochlorideclomipramine hydrochlorideGolden State Medical SupplyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8472ORIG1998-04-30