FDA.reportPublic FDA data

Application 205187

Type
ANDA
Sponsor
MICRO LABS LTD INDIA

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
42571-163Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-163Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-163Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-164Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-164Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent
42571-164Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumMicro Labs LimitedANDACurrent