FDA.reportPublic FDA data

Application 065418

Type
ANDA
Sponsor
ORCHID HLTHCARE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42043-250CefdinirCefdinirOrchidPharma IncANDACurrent
43063-597CefdinirCefdinirPD-Rx Pharmaceuticals, InANDACurrent
63187-593CefdinirCefdinirProficient Rx LPANDACurrent
67296-1291CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-1291CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
68071-3032CefdinirCefdinirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3032CefdinirCefdinirNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9760CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-9760CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent