FDA.report

Application 065064

Type
ANDA
Sponsor
SANDOZ

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL500MG;EQ 125MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
43858-606Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-606Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
55700-375Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-375Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-375Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-803Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-803Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-2630Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7965Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7965Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9316Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
69452-336Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
69452-336Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
70518-3523Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumREMEDYREPACK INC.ANDACurrent
72189-281AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxANDACurrent
72189-281AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxANDACurrent
76420-507Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAsclemed USA, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
8382ORIG2002-03-15