FDA.reportPublic FDA data

Application 206987

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BOSENTANBOSENTANTABLET;ORAL62.5MGNoNo
002BOSENTANBOSENTANTABLET;ORAL125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-386BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-386BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-386BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-386BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-386BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-387BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-387BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-387BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-387BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent
68180-387BosentanBosentanLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76403ORIG 2023-11-06