FDA.reportPublic FDA data

Application 205707

Type
ANDA
Sponsor
MICRO LABS LTD INDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL250MG;EQ 125MG BASENoNo
002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL500MG;EQ 125MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-160AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
50090-4604AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-4604AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-4604AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
53002-2392AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
68071-4275AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4275AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4284AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4284AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4284AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4300AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4300AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4300AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7998AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7998AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-2625AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumREMEDYREPACK INC.ANDACurrent
70518-2625AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumREMEDYREPACK INC.ANDACurrent
70518-2625AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumREMEDYREPACK INC.ANDACurrent
70518-2625AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumREMEDYREPACK INC.ANDACurrent
70934-057AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-057AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-057AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-057AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc.ANDACurrent
70934-126AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-126AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-126AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-126AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-014AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
71205-014AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
71205-014AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
71205-014AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
71205-014AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent