Application 211067

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL20MEQ/15MLNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL40MEQ/15MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7061Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7061Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7062Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
48433-217POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
48433-217POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
48433-218POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
48433-218POTASSIUM CHLORIDEPOTASSIUM CHLORIDESafecor Health, LLCANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6184Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent
60505-6185Potassium ChloridePotassium ChlorideApotex CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55182ORIG2018-08-16