FDA.reportPublic FDA data

Application 075155

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL30MGNoNo
003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL120MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-575isosorbide mononitrateisosorbide mononitrateRebel Distributors CorpANDACurrent
21695-777isosorbide mononitrateisosorbide mononitrateRebel Distributors CorpANDACurrent
21695-837isosorbide mononitrateisosorbide mononitrateRebel Distributors CorpANDACurrent
43063-313isosorbide mononitrateisosorbide mononitratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-313isosorbide mononitrateisosorbide mononitratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-313isosorbide mononitrateisosorbide mononitratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-313isosorbide mononitrateisosorbide mononitratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-313isosorbide mononitrateisosorbide mononitratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-917isosorbide mononitrateisosorbide mononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-917isosorbide mononitrateisosorbide mononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0787isosorbide mononitrateisosorbide mononitrateA-S Medication SolutionsANDACurrent
50090-2077isosorbide mononitrateisosorbide mononitrateA-S Medication SolutionsANDACurrent
50268-451isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-451isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-451isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-452isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-452isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-452isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-453isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-453isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50268-453isosorbide mononitrateisosorbide mononitrateAvPAKANDACurrent
50436-3944isosorbide mononitrateisosorbide mononitrateUnit Dose ServicesANDACurrent
55154-4785isosorbide mononitrateisosorbide mononitrateCardinal HealthANDACurrent
55154-4785isosorbide mononitrateisosorbide mononitrateCardinal HealthANDACurrent
55154-4785isosorbide mononitrateisosorbide mononitrateCardinal HealthANDACurrent
55154-4786isosorbide mononitrateisosorbide mononitrateCardinal HealthANDACurrent
55154-4786isosorbide mononitrateisosorbide mononitrateCardinal HealthANDACurrent
55154-4786isosorbide mononitrateisosorbide mononitrateCardinal HealthANDACurrent
55700-123isosorbide mononitrateisosorbide mononitrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
62175-119isosorbide mononitrateisosorbide mononitrateLannett Company, Inc..ANDACurrent
62175-119isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-119isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-119isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-128isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-128isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-128isosorbide mononitrateisosorbide mononitrateLannett Company, Inc..ANDACurrent
62175-128isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-129isosorbide mononitrateisosorbide mononitrateLannett Company, Inc..ANDACurrent
62175-129isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-129isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
62175-129isosorbide mononitrateisosorbide mononitrateLannett Company, Inc.ANDACurrent
63629-1424isosorbide mononitrateisosorbide mononitrateBryant Ranch PrepackANDACurrent
63629-1424isosorbide mononitrateisosorbide mononitrateBryant Ranch PrepackANDACurrent
63629-1424isosorbide mononitrateisosorbide mononitrateBryant Ranch PrepackANDACurrent
63629-1823isosorbide mononitrateisosorbide mononitrateBryant Ranch PrepackANDACurrent
63629-1823isosorbide mononitrateisosorbide mononitrateBryant Ranch PrepackANDACurrent
67544-224isosorbide mononitrateisosorbide mononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-224isosorbide mononitrateisosorbide mononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-236isosorbide mononitrateisosorbide mononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-236isosorbide mononitrateisosorbide mononitrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-1926isosorbide mononitrateisosorbide mononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3266isosorbide mononitrateisosorbide mononitrateNuCare Pharmaceuticals, Inc.ANDACurrent
68084-591isosorbide mononitrateisosorbide mononitrateAmerican Health PackagingANDACurrent
68084-591Isosorbide MononitrateIsosorbide MononitrateAmerican Health PackagingANDACurrent
68084-591Isosorbide MononitrateIsosorbide MononitrateAmerican Health PackagingANDACurrent
68084-591Isosorbide MononitrateIsosorbide MononitrateAmerican Health PackagingANDACurrent
68084-592isosorbide mononitrateisosorbide mononitrateAmerican Health PackagingANDACurrent
68084-592Isosorbide MononitrateIsosorbide MononitrateAmerican Health PackagingANDACurrent
68084-592Isosorbide MononitrateIsosorbide MononitrateAmerican Health PackagingANDACurrent
68084-592Isosorbide MononitrateIsosorbide MononitrateAmerican Health PackagingANDACurrent
68151-1420isosorbide mononitrateisosorbide mononitrateCarilion Materials ManagementANDACurrent
68788-6863isosorbide mononitrateisosorbide mononitratePreferred Pharmaceuticals Inc.ANDACurrent
70518-0009isosorbide mononitrateisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-2201isosorbide mononitrateisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-2201isosorbide mononitrateisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-2201isosorbide mononitrateisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70518-3132isosorbide mononitrateisosorbide mononitrateREMEDYREPACK INC.ANDACurrent
70934-573isosorbide mononitrateisosorbide mononitrateDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39459SUPPL2014-10-24
8543SUPPL2014-10-24
8542ORIG1998-10-30