FDA.reportPublic FDA data

Application 016093

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDECRINETHACRYNATE SODIUMINJECTABLE;INJECTIONEQ 50MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25010-210SODIUM EDECRINethacrynate sodiumAton Pharma, Inc.NDACurrent
25010-210SODIUM EDECRINethacrynate sodiumBausch Health US, LLCNDACurrent
25010-210SODIUM EDECRINethacrynate sodiumBausch Health US, LLCNDACurrent
25010-210SODIUM EDECRINethacrynate sodiumBausch Health US, LLCNDACurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-012ethacrynic sodiumethacrynic sodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33145SUPPL2005-02-11
12974SUPPL2005-02-11
12973SUPPL2004-03-02
40704SUPPL1999-10-19