FDA.reportPublic FDA data

Application 065189

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL250MG;EQ 125MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
43858-607Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-607Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
53808-0759Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMState of Florida DOH Central PharmacyANDACurrent
70882-111Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumCambridge Therapeutics Technologies, LLCANDACurrent
76420-503Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22319ORIG2008-07-31