FDA.reportPublic FDA data

Application 016092

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDECRINETHACRYNIC ACIDTABLET;ORAL25MGYesYes
002EDECRINETHACRYNIC ACIDTABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25010-215EDECRINethacrynic acidAton Pharma, Inc.NDACurrent
25010-215EDECRINethacrynic acidBausch Health US, LLCNDACurrent
25010-215EDECRINethacrynic acidBausch Health US, LLCNDACurrent
25010-215EDECRINethacrynic acidBausch Health US, LLCNDACurrent
68682-011ethacrynic acidethacrynic acidOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-011ethacrynic acidethacrynic acidOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-011ethacrynic acidethacrynic acidOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
69189-0371EDECRINethacrynic acidAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10870SUPPL2005-02-11
416SUPPL2005-02-11
12972SUPPL2004-03-02
40703SUPPL1999-10-19