FDA.reportPublic FDA data

Application 212121

Type
NDA
Sponsor
CMP DEV LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASICSOLUTION;INTRAVENOUS4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46287-024POTASSIUM PHOSPHATESmonobasic potassium phosphate and dibasic potassium phosphateCMP PHARMA, INC.NDACurrent
46287-024POTASSIUM PHOSPHATESmonobasic potassium phosphate and dibasic potassium phosphateCMP PHARMA, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62809ORIG2020-05-04
60082ORIG2019-09-20
60081ORIG2019-09-20