FDA.reportPublic FDA data

Application 203661

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo
003CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9833CEFAZOLINcefazolinHenry Schein, Inc.ANDACurrent
0404-9833CEFAZOLINcefazolinHenry Schein, Inc.ANDACurrent
0404-9833CEFAZOLINcefazolinHenry Schein, Inc.ANDACurrent
0404-9833CEFAZOLINcefazolinHenry Schein, Inc.ANDACurrent
52584-087CEFAZOLINcefazolinGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-087CEFAZOLINcefazolinGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-087CEFAZOLINcefazolinGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-087CEFAZOLINcefazolinGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-087CEFAZOLINcefazolinGeneral Injectables & Vaccines, Inc.ANDACurrent
60505-6142CefazolinCefazolinApotex Corp.ANDACurrent
60505-6142CefazolinCEFAZOLINApotex Corp.ANDACurrent
60505-6142CefazolinCEFAZOLINApotex Corp.ANDACurrent
60505-6142CefazolinCEFAZOLINApotex Corp.ANDACurrent
60505-6142CefazolinCefazolinApotex Corp.ANDACurrent
60505-6231CefazolinCefazolinApotex Corp.ANDACurrent
60505-6243CefazolinCefazolinApotex Corp.ANDACurrent
67184-0560CefazolinCefazolinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1001CefazolinCEFAZOLINQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1001CefazolinCefazolinQilu Pharmaceutical Co., Ltd.ANDACurrent
70518-3047CefazolinCEFAZOLINREMEDYREPACK INC.ANDACurrent
70518-3047CefazolinCefazolinREMEDYREPACK INC.ANDACurrent
71205-679CefazolinCefazolinProficient Rx LPANDACurrent
71872-7141CefazolinCEFAZOLINMedical Purchasing Solutions, LLCANDACurrent
71872-7141CefazolinCEFAZOLINMedical Purchasing Solutions, LLCANDACurrent