FDA.reportPublic FDA data

Application 201444

Type
NDA
Sponsor
HOPE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITHIODOTESODIUM NITRITE; SODIUM THIOSULFATESOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60267-812NITHIODOTESodium Nitrite and Sodium ThiosulfateHope PharmaceuticalsNDACurrent
60267-812NITHIODOTESodium Nitrite and Sodium ThiosulfateHope PharmaceuticalsNDACurrent
60267-812NITHIODOTESodium Nitrite and Sodium ThiosulfateHope PharmaceuticalsNDACurrent
60267-812NITHIODOTESodium Nitrite and Sodium ThiosulfateHope PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65906SUPPL2021-01-14
65903SUPPL2021-01-14
50161SUPPL2017-10-24
50135SUPPL2017-10-23
43366ORIG2012-02-10
24393ORIG2012-02-10
19017ORIG2011-01-20
9895ORIG2011-01-20