Application 050588

Type
NDA
Sponsor
TELIGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFOTANCEFOTETAN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALYesNo
002CEFOTANCEFOTETAN DISODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALYesNo
003CEFOTANCEFOTETAN DISODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52565-052CefotanCefotetan DisodiumTeligent Pharma, Inc.NDACurrent
52565-053CEFOTANcefotetan disodiumTeligent Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57692ORIG2019-02-15
47552SUPPL2017-03-14
47520SUPPL2017-03-10
39014SUPPL2004-07-01
30128SUPPL2004-07-01
17906SUPPL2004-05-28
17907SUPPL2003-07-08
7856SUPPL2003-07-06
30127SUPPL2003-03-10