FDA.reportPublic FDA data

Application 065264

Type
ANDA
Sponsor
LUPIN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-1150CefdinirCefdinirAtlantic Biologicals CorpsANDACurrent
43063-466CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1033CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-1033CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-1033CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-1034CefdinirCefdinirA-S Medication SolutionsANDACurrent
55700-764CefdinirCefdinirQuality Care Products, LLCANDACurrent
55700-764CefdinirCefdinirQuality Care Products, LLCANDACurrent
55700-764CefdinirCefdinirQuality Care Products, LLCANDACurrent
55700-764CefdinirCefdinirQuality Care Products, LLCANDACurrent
57297-711CefdinirCefdinirLUPIN LIMITEDANDACurrent
67296-0469CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-0469CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-0469CefdinirCefdinirRedPharm Drug Inc.ANDACurrent
68001-150CefdinirCefdinirBluePoint LaboratoriesANDACurrent
68071-4856CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4856CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68180-711CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-711CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-711CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
70518-3577CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70934-343CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-343CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-343CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8393ORIG2006-05-22