FDA.reportPublic FDA data

Application 065066

Type
ANDA
Sponsor
SANDOZ

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/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-6102Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6102Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6102Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6102Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6102Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6104Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6104Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6104Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6104Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-6104Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
21695-546Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRebel Distributors Corp.ANDACurrent
21695-767Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRebel Distributors CorpANDACurrent
43858-604Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-604Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-605Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-605Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
68071-5216Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5216Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7155Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8000Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8000Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8305Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
69452-334Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
69452-334Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
69452-335Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
69452-335Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42805ORIG2007-04-02
8383ORIG2003-04-09