FDA.report

Application 090598

Type
ANDA
Sponsor
VINTAGE PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL120MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4110Isosorbide MononitrateIsosorbide MononitratePar PharmaceuticalANDACurrent
0603-4111Isosorbide MononitrateIsosorbide MononitratePar PharmaceuticalANDACurrent
0603-4112Isosorbide MononitrateIsosorbide MononitratePar PharmaceuticalANDACurrent
0615-7756Isosorbide MononitrateIsosorbide MononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7757Isosorbide MononitrateIsosorbide MononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-2554Isosorbide MononitrateIsosorbide MononitrateA-S Medication SolutionsANDACurrent
63187-700Isosorbide MononitrateIsosorbide MononitrateProficient Rx LPANDACurrent
63187-700Isosorbide MononitrateIsosorbide MononitrateProficient Rx LPANDACurrent
63629-7477Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent
68071-1953Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3296Isosorbide MononitrateIsosorbide MononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
71335-0431Isosorbide MononitrateIsosorbide MononitrateBryant Ranch PrepackANDACurrent