FDA.reportPublic FDA data

Application 065392

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATECAPSULE;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-135CefadroxilCefadroxilBlenheim Pharmacal, Inc.ANDACurrent
33261-018CefadroxilCefadroxilAidarex Pharmaceuticals LLCANDACurrent
42254-146CefadroxilCefadroxilRebel Distributors CorpANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, InANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-553CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-503CefadroxilCefadroxilmedsource pharmaceutocalsANDACurrent
50090-0580CefadroxilCefadroxilA-S Medication SolutionsANDACurrent
52959-428CefadroxilCefadroxilH.J. Harkins Company, Inc.ANDACurrent
53002-2290CefadroxilCefadroxilRPK Pharmaceuticals, Inc.ANDACurrent
53002-2290CefadroxilCefadroxilRPK Pharmaceuticals, Inc.ANDACurrent
57297-180CefadroxilCefadroxilLUPIN LIMITEDANDACurrent
63187-883CefadroxilCefadroxilProficient Rx LPANDACurrent
63187-883CefadroxilCefadroxilProficient Rx LPANDACurrent
63187-883CefadroxilCefadroxilProficient Rx LPANDACurrent
63187-883CefadroxilCefadroxilProficient Rx LPANDACurrent
63629-1358CefadroxilCefadroxilBryant Ranch PrepackANDACurrent
66267-045CefadroxilCefadroxilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-045CefadroxilCefadroxilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-045CefadroxilCefadroxilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4690CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4690CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68180-180CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent
68180-180CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent
68180-180CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent
68788-0708CefadroxilCefadroxilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-0708CefadroxilCefadroxilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8261CefadroxilCefadroxilPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3580CefadroxilCefadroxilREMEDYREPACK INC.ANDACurrent
70518-3580CefadroxilCefadroxilREMEDYREPACK INC.ANDACurrent
70934-081CefadroxilCefadroxilDenton Pharma, Inc. DBA NANDACurrent
70934-081CefadroxilCefadroxilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-081CefadroxilCefadroxilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent