FDA.reportPublic FDA data

Application 065141

Type
ANDA
Sponsor
SAMSON MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 100GM BASE/VIALNoYes
002CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 300GM BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66288-1100CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1100CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1100CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1100CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1300CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1300CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1300CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent
66288-1300CEFAZOLINCEFAZOLIN SODIUMSamson Medical Technologies, L.L.C.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30654SUPPL2014-02-26
39418SUPPL2014-02-06