FDA.reportPublic FDA data

Application 065259

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFDINIRCEFDINIRFOR SUSPENSION;ORAL125MG/5MLNoNo
002CEFDINIRCEFDINIRFOR SUSPENSION;ORAL250MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-905CefdinirCefdinirAidarex Pharmaceuticals LLCANDACurrent
42254-127CefdinirCefdinirRebel Distributors CorpANDACurrent
50090-3723CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-3723CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-3723CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-3723CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-3724CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-3724CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-6171CefdinirCefdinirA-S Medication SolutionsANDACurrent
57297-722CefdinirCefdinirLUPIN LIMITEDANDACurrent
57297-723CefdinirCefdinirLUPIN LIMITEDANDACurrent
68180-722CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-722CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-722CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-722CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-723CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-723CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-723CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68180-723CefdinirCefdinirLupin Pharmaceuticals, Inc.ANDACurrent
68258-3053CefdinirCefdinirDispensing Solutions, Inc.ANDACurrent
68788-7062CefdinirCefdinirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7062CefdinirCefdinirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7062CefdinirCefdinirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7062CefdinirCefdinirPreferred Pharmaceuticals, Inc.ANDACurrent
71205-380CefdinirCefdinirProficient Rx LPANDACurrent
71205-380CefdinirCefdinirProficient Rx LPANDACurrent
71205-380CefdinirCefdinirProficient Rx LPANDACurrent
72189-042CEFDINIRCEFDINIRDirect_RxANDACurrent
72189-043CEFDINIRCEFDINIRDIRECT RXANDACurrent
72189-043CEFDINIRCEFDINIRDIRECT RXANDACurrent
72189-043CEFDINIRCEFDINIRDIRECT RXANDACurrent
72189-043CEFDINIRCEFDINIRDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8391ORIG2006-06-02