FDA.report

Application 076140

Type
ANDA
Sponsor
APOTEX

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL80MGNoNo
002SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL120MGNoNo
003SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL160MGNoNo
004SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL240MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7888Sotalol HydrochlorideSotalol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-7143Sotalol HydrochlorideSotalol HydrochlorideMajor PharmaceuticalsANDACurrent
50090-1299Sotalol HydrochlorideSotalol HydrochlorideA-S Medication SolutionsANDACurrent
50090-1299Sotalol HydrochlorideSotalol HydrochlorideA-S Medication SolutionsANDACurrent
50090-1299Sotalol HydrochlorideSotalol HydrochlorideA-S Medication SolutionsANDACurrent
50090-1299Sotalol HydrochlorideSotalol HydrochlorideA-S Medication SolutionsANDACurrent
50090-1299Sotalol HydrochlorideSotalol HydrochlorideA-S Medication SolutionsANDACurrent
50268-724Sotalol HydrochlorideSotalol HydrochlorideAvPAKANDACurrent
50268-724Sotalol HydrochlorideSotalol HydrochlorideAvPAKANDACurrent
50268-725Sotalol HydrochlorideSotalol HydrochlorideAvPAKANDACurrent
50268-725Sotalol HydrochlorideSotalol HydrochlorideAvPAKANDACurrent
53217-011Sotalol HydrochlorideSotalol HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55154-8179Sotalol HydrochlorideSotalol HydrochlorideCardinal HealthANDACurrent
55154-8179Sotalol HydrochlorideSotalol HydrochlorideCardinal HealthANDACurrent
55154-8179Sotalol HydrochlorideSotalol HydrochlorideCardinal Health 107, LLCANDACurrent
55154-8179Sotalol HydrochlorideSotalol HydrochlorideCardinal HealthANDACurrent
60429-748Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-748Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-748Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-748Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-748Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-749Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-749Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-749Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-749Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-749Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-750Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-750Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-750Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-750Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-750Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-751Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-751Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-751Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-751Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-751Sotalol HydrochlorideSotalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60505-0080Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0080Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0080Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0080Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0081Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0081Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0081Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0081Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0082Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0082Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0082Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0082Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0159Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0159Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0159Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0159Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
63187-804Sotalol HydrochlorideSotalol HydrochlorideProficient Rx LPANDACurrent
63187-804Sotalol HydrochlorideSotalol HydrochlorideProficient Rx LPANDACurrent
63187-804Sotalol HydrochlorideSotalol HydrochlorideProficient Rx LPANDACurrent
68084-654Sotalol HydrochlorideSotalol HydrochlorideAmerican Health PackagingANDACurrent
68084-654Sotalol HydrochlorideSotalol HydrochlorideAmerican Health PackagingANDACurrent
68084-654Sotalol HydrochlorideSotalol HydrochlorideAmerican Health PackagingANDACurrent
68084-654Sotalol HydrochlorideSotalol HydrochlorideAmerican Health PackagingANDACurrent
68084-654Sotalol HydrochlorideSotalol HydrochlorideAmerican Health PackagingANDACurrent
70518-3341Sotalol HydrochlorideSotalol HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0260Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-0260Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-0260Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1125Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1125Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71610-294Sotalol HydrochlorideSotalol HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent