FDA.reportPublic FDA data

Application 210534

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFDINIRCEFDINIRFOR SUSPENSION;ORAL125MG/5MLNoNo
002CEFDINIRCEFDINIRFOR SUSPENSION;ORAL250MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5811cefdinircefdinirA-S Medication SolutionsANDACurrent
67877-547cefdinircefdinirAscend Laboratories, LLCANDACurrent
67877-547cefdinircefdinirAscend Laboratories, LLCANDACurrent
67877-547cefdinircefdinirAscend Laboratories, LLCANDACurrent
67877-548cefdinircefdinirAscend Laboratories, LLCANDACurrent
67877-548cefdinircefdinirAscend Laboratories, LLCANDACurrent
67877-548cefdinircefdinirAscend Laboratories, LLCANDACurrent
68071-2493cefdinircefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2493cefdinircefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2564cefdinircefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2683CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8062cefdinircefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-8062cefdinircefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-8115cefdinircefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-8115cefdinircefdinirPreferred Pharmaceuticals Inc.ANDACurrent
72189-259CEFDINIRCEFDINIRDIRECT RXANDACurrent
72189-259CEFDINIRCEFDINIRDIRECT RXANDACurrent