FDA.reportPublic FDA data

Application 065162

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL600MG/5ML;EQ 42.9MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8675Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8675Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
45865-928Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassiummedsource pharmaceuticalsANDACurrent
50090-3293Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50090-3293Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumA-S Medication SolutionsANDACurrent
50436-5166Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumUnit Dose ServicesANDACurrent
50436-8675Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumUnit Dose ServicesANDACurrent
53002-1716Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1716Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
55700-471Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-857Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-4360Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4360Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4373Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4373Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4373Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7127Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8388SUPPL2010-11-10
18331SUPPL2010-10-26
22317ORIG2007-07-06