FDA.reportPublic FDA data

Application 065330

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFDINIRCEFDINIRCAPSULE;ORAL300MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-2176CefdinirCefdinirSandoz IncANDACurrent
0781-2176CefdinirCefdinirSandoz IncANDACurrent
0781-2176CefdinirCefdinirSandoz IncANDACurrent
43063-852CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-853CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1661CefdinirCefdinirA-S Medication SolutionsANDACurrent
51655-019CEFDINIRCEFDINIRNorthwind Pharmaceuticals, LLCANDACurrent
55700-214CefdinirCefdinirLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-989CefdinirCefdinirProficient Rx LPANDACurrent
63187-989CefdinirCefdinirProficient Rx LPANDACurrent
67253-011CefdinirCefdinirDAVA Pharmaceuticals IncANDACurrent
67296-0765CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-0765CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-0765CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-1232CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-1232CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
68788-7111CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7111CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7111CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
70934-164CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-164CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-164CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent