FDA.reportPublic FDA data

Application 210220

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFDINIRCEFDINIRCAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6041CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-6042CefdinirCefdinirA-S Medication SolutionsANDACurrent
63629-8968CefdinirCefdinirBryant Ranch PrepackANDACurrent
63629-8969CefdinirCefdinirBryant Ranch PrepackANDACurrent
67877-524CefdinirCefdinirAscend Laboratories, LLCANDACurrent
67877-543CefdinirCefdinirAscend Laboratories, LLCANDACurrent
67877-543CefdinirCefdinirAscend Laboratories, LLCANDACurrent
68071-2401CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2401CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2503CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7987CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7987CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
71205-576CefdinirCefdinirProficient Rx LPANDACurrent
71205-576CefdinirCefdinirProficient Rx LPANDACurrent
72189-308CEFDINIRCEFDINIRDirectRxANDACurrent
72189-308CEFDINIRCEFDINIRDirectRxANDACurrent