FDA.reportPublic FDA data

Application 019194

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYPRINETRIENTINE HYDROCHLORIDECAPSULE;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-2120Syprinetrientine hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health US LLCNDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health US LLCNDACurrent
0187-2120Syprinetrientine hydrochlorideBausch Health US LLCNDACurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent
68682-212Trientine Hydrochloridetrientine hydrochlorideOceanside PharmaceutialsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20212SUPPL2001-06-08
57418ORIG1985-10-31