FDA.reportPublic FDA data

Application 065089

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL200MG/5ML;EQ 28.5MG BASE/5MLNoNo
002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL400MG/5ML;EQ 57MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2277Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2277Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2277Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2277Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2279Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2279Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2279Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2279Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3047Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
53002-0100Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
63187-770Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-770Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-770Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-770Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-5208Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5208Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7128Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7128Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7128Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7128Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7128Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42808ORIG2007-06-11