FDA.reportPublic FDA data

Application 065093

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL875MG;EQ 125MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-951Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumBlenheim Pharmacal, Inc.ANDACurrent
16714-478Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNorthstar RxLLCANDACurrent
16714-478Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNorthstar RxLLCANDACurrent
50090-4922Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumA-S Medication SolutionsANDACurrent
50436-1001Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumUnit Dose ServicesANDACurrent
53002-7891Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-7891Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-7898Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-7898Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53808-0740Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMState of Florida DOH Central PharmacyANDACurrent
55700-456Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-637AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRXANDACurrent
61919-637AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRXANDACurrent
63187-423Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
63187-423Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
63187-423Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
63187-423Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
66685-1001Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1001Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
66685-1001Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumSandoz IncANDACurrent
68071-2851Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4193Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4204Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4205Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9319Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9319Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9319Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9319Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9319Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1508Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70518-1508Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70518-2325Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70518-2325Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70518-2325Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70518-2325Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70518-2325Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumREMEDYREPACK INC.ANDACurrent
70934-086Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-086Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-086Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-086Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-719Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumProficient Rx LPANDACurrent
80425-0217Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22311ORIG2005-07-22