FDA.reportPublic FDA data

Application 075522

Type
ANDA
Sponsor
DEXCEL LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-178Isosorbide MononitrateIsosorbide MononitrateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-178Isosorbide MononitrateIsosorbide MononitrateHeritage Pharmaceuticals Inc.ANDACurrent
23155-178Isosorbide MononitrateIsosorbide MononitrateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-178Isosorbide MononitrateIsosorbide MononitrateAvet Pharmaceuticals Inc.ANDACurrent
23155-519Isosorbide MononitrateIsosorbide MononitrateHeritage Pharmaceuticals Inc.ANDACurrent
23155-519Isosorbide MononitrateIsosorbide MononitrateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-519Isosorbide MononitrateIsosorbide MononitrateAvet Pharmaceuticals Inc.ANDACurrent
23155-519Isosorbide MononitrateIsosorbide MononitrateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
50090-4009Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-4009Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-4009Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-4047Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-4047Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50090-4047Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
50436-3945Isosorbide MononitrateIsosorbide MononitrateUnit Dose ServicesANDACurrent
53002-1570Isosorbide MononitrateIsosorbide MononitrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1570Isosorbide MononitrateIsosorbide MononitrateRPK Pharmaceuticals, Inc.ANDACurrent
68071-3081Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3081Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3081Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4290Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4290Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4290Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2122Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2122Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2122Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2122Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2122Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2122Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2207Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2207Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2207Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2207Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2692Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2692Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70518-2692Isosorbide MononitrateIsosorbide MononitrateREMEDYREPACK INC.ANDACurrent
70934-183Isosorbide MononitrateIsosorbide MononitrateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-183Isosorbide MononitrateIsosorbide MononitrateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-972Isosorbide MononitrateIsosorbide MononitrateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0037Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
71335-0037Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
71335-0037Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
71335-1117Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
71335-1117Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43000ORIG2000-04-17
30922ORIG2000-04-17