FDA.reportPublic FDA data

Application 211648

Type
ANDA
Sponsor
SAPTALIS PHARMS

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
42571-357POTASSIUM CHLORIDEPOTASSIUM CHLORIDEMICRO LABS LIMITEDANDACurrent
42571-358POTASSIUM CHLORIDEPOTASSIUM CHLORIDEMICRO LABS LIMITEDANDACurrent
60687-628POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health PackagingANDACurrent
81033-220POTASSIUM CHLORIDEPOTASSIUM CHLORIDEKesin Pharma CorporationANDACurrent
81033-240POTASSIUM CHLORIDEPOTASSIUM CHLORIDEKesin Pharma CorporationANDACurrent