FDA.report

Application 078423

Type
ANDA
Sponsor
HARRIS PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLETABLET;ORAL50MGNoNo
002FLUCONAZOLEFLUCONAZOLETABLET;ORAL100MGNoNo
003FLUCONAZOLEFLUCONAZOLETABLET;ORAL150MGNoNo
004FLUCONAZOLEFLUCONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3194FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3194FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3194FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3196FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3196FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3196FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3899FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3899FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
51407-299FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-299FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-300FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-300FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-301FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-301FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-302FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-302FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
53002-1198FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-1198FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-4400FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-4400FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
55700-490FluconazoleFluconazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-521FluconazoleFluconazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-521FluconazoleFluconazoleLake Erie Medical DBA QuaANDACurrent
55700-521FluconazoleFluconazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
62559-990FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-990FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-990FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-991FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-991FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-991FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-992FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-992FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-992FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-993FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-993FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-993FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
63629-1947FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1947FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1947FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1949FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1949FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1949FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1950FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1950FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1950FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-7986FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-7986FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8970FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8970FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8971FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8971FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9091FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9091FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9134FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9134FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent