FDA.report

Application 065063

Type
ANDA
Sponsor
SANDOZ

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL875MG;EQ 125MG BASENoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1852Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1852Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1852Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1852Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1852Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
16714-014Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-014Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-014Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
43858-601Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-601Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
55700-306Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-444Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-488Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-488Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-488Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-488Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-2853Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3082Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3161Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7958Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7958Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
69452-337Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
69452-337Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
71205-651Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
71205-712Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
76420-501Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAsclemed USA, Inc.ANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
306460ORIG12002-03-14