FDA.reportPublic FDA data

Application 012093

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISORDILISOSORBIDE DINITRATETABLET;ORAL40MGYesYes
002ISORDILISOSORBIDE DINITRATETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005ISORDILISOSORBIDE DINITRATETABLET;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006ISORDILISOSORBIDE DINITRATETABLET;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
007ISORDILISOSORBIDE DINITRATETABLET;ORAL5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0152Isordilisosorbide dinitrateValeant Pharmaceuticals North America LLCNDACurrent
0187-0152Isordilisosorbide dinitrateBausch Health Americas, IncNDACurrent
0187-0152Isordilisosorbide dinitrateBausch Health US LLCNDACurrent
0187-0152Isordilisosorbide dinitrateBausch Health US LLCNDACurrent
0187-0192Isordilisosorbide dinitrateValeant Pharmaceuticals North America LLCNDACurrent
0187-0192Isordilisosorbide dinitrateBausch Health Americas, IncNDACurrent
0187-0192Isordilisosorbide dinitrateBausch Health US LLCNDACurrent
0187-0192Isordilisosorbide dinitrateBausch Health US LLCNDACurrent
68682-192Isosorbide Dinitrateisosorbide dinitrateOceanside PharmaceuticalsNDACurrent
68682-193Isosorbide Dinitrateisosorbide dinitrateOceanside PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11987SUPPL2015-01-16
33072SUPPL2015-01-15
11986SUPPL2001-09-26