FDA.report

Application 065496

Type
ANDA
Sponsor
ALKEM LABS LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 250MG BASENoNo
002CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-656Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-657Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2157Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2157Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2157Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2158Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2158Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2158Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2159Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
50090-2159Cefuroxime axetilCefuroxime axetilA-S Medication SolutionsANDACurrent
51407-333Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-333Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-333Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-333Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-334Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-334Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-334Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
51407-334Cefuroxime axetilCefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
52959-308Cefuroxime axetilCefuroxime axetilH.J. Harkins Company, Inc.ANDACurrent
53002-2670Cefuroxime axetilCefuroxime axetilRPK Pharmaceuticals, Inc.ANDACurrent
53002-2750Cefuroxime axetilCefuroxime axetilRPK Pharmaceuticals, Inc.ANDACurrent
55700-655Cefuroxime axetilCefuroxime axetilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-655Cefuroxime axetilCefuroxime axetilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-655Cefuroxime axetilCefuroxime axetilLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-272Cefuroxime axetilCefuroxime axetilAmerican Health PackagingANDACurrent
60687-272Cefuroxime axetilCefuroxime axetilAmerican Health PackagingANDACurrent
60687-272Cefuroxime axetilCefuroxime axetilAmerican Health PackagingANDACurrent
60687-272Cefuroxime axetilCefuroxime axetilAmerican Health PackagingANDACurrent
60687-272Cefuroxime axetilCefuroxime axetilAmerican Health PackagingANDACurrent
61919-747CEFUROXIME AXETILCEFUROXIME AXETILDirect_RxANDACurrent
61919-747CEFUROXIME AXETILCEFUROXIME AXETILDirect_RxANDACurrent
63187-991Cefuroxime axetilCefuroxime axetilProficient Rx LPANDACurrent
63187-991Cefuroxime axetilCefuroxime axetilProficient Rx LPANDACurrent
63187-991Cefuroxime axetilCefuroxime axetilProficient Rx LPANDACurrent
63629-9446Cefuroxime axetilCefuroxime axetilBryant Ranch PrepackANDACurrent
63629-9447Cefuroxime axetilCefuroxime axetilBryant Ranch PrepackANDACurrent
63629-9448Cefuroxime axetilCefuroxime axetilBryant Ranch PrepackANDACurrent
63629-9449Cefuroxime axetilCefuroxime axetilBryant Ranch PrepackANDACurrent
67877-215Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-215Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-215Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-215Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-216Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-216Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-216Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
67877-216Cefuroxime axetilCefuroxime axetilAscend Laboratories, LLCANDACurrent
68071-1637Cefuroxime axetilCefuroxime axetilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1637Cefuroxime axetilCefuroxime axetilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1637Cefuroxime axetilCefuroxime axetilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4947Cefuroxime axetilCefuroxime axetilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4947Cefuroxime axetilCefuroxime axetilNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2694Cefuroxime axetilCefuroxime axetilREMEDYREPACK INC.ANDACurrent
70518-2694Cefuroxime axetilCefuroxime axetilREMEDYREPACK INC.ANDACurrent
70518-2694Cefuroxime axetilCefuroxime axetilREMEDYREPACK INC.ANDACurrent
72789-035Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-035Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-035Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-035Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-035Cefuroxime axetilCefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent