FDA.reportPublic FDA data

Application 065248

Type
ANDA
Sponsor
ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 250MG BASENoNo
002CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-503CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
12634-434cephalexincephalexinApotheca Inc.ANDACurrent
42043-140cephalexincephalexinOrchidPharma IncANDACurrent
42043-140cephalexincephalexinOrchidPharma IncANDACurrent
42043-141cephalexincephalexinOrchidPharma IncANDACurrent
42043-141cephalexincephalexinOrchidPharma IncANDACurrent
49364-110CephalexinCephalexinStrategic Pharmaceutical Solutions, Inc. DBA VetSourceANDACurrent
49364-111CephalexinCephalexinStrategic Pharmaceutical Solutions, Inc. DBA VetSourceANDACurrent
51655-720CephalexinCephalexinNorthwind PharmaceuticalsANDACurrent
61919-035CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
61919-035CEPHALEXINCEPHALEXINDirect_RxANDACurrent
61919-035CEPHALEXINCEPHALEXINDirect_RxANDACurrent
61919-410KEFLEXCEPHALEXINDIRECT RXANDACurrent
63187-592cephalexincephalexinProficient Rx LPANDACurrent
63187-699cephalexincephalexinProficient Rx LPANDACurrent
63629-7605cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7606cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7607cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7618cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7618cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7628cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7630cephalexincephalexinBryant Ranch PrepackANDACurrent
66116-388cephalexincephalexinMedVantx, Inc.ANDACurrent
66267-049cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-049cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-050cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-050cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-769cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-769cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-770cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-770cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1292cephalexincephalexinRedPharm Drug, Inc.ANDACurrent
67296-1292cephalexincephalexinRedPharm Drug, Inc.ANDACurrent
68788-9950cephalexincephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9951cephalexincephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0826CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-0826CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-0912cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-0912cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-0957CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-0957CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-1148cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-1148cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-1379cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-1379cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70934-034cephalexincephalexinDenton Pharma, Inc.ANDACurrent
70934-037cephalexincephalexinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76420-035cephalexincephalexinAsclemed USA, Inc.ANDACurrent