FDA.reportPublic FDA data

Application 019071

Type
NDA
Sponsor
MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UROCIT-KPOTASSIUM CITRATETABLET, EXTENDED RELEASE;ORAL5MEQYesNo
002UROCIT-KPOTASSIUM CITRATETABLET, EXTENDED RELEASE;ORAL10MEQYesNo
003UROCIT-KPOTASSIUM CITRATETABLET, EXTENDED RELEASE;ORAL15MEQYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0600UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0610UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0178-0615UROCIT-Kpotassium citrateMission Pharmacal CompanyNDACurrent
0245-0070Potassium Citratepotassium citrateUpsher-Smith Laboratories, LLCNDACurrent
0245-0070Potassium Citratepotassium citrateUpsher-Smith Laboratories, LLCNDACurrent
0245-0070Potassium Citratepotassium citrateUpsher-Smith Laboratories, LLCNDACurrent
0245-0071Potassium Citratepotassium citrateUpsher-Smith Laboratories, LLCNDACurrent
0245-0071Potassium Citratepotassium citrateUpsher-Smith Laboratories, LLCNDACurrent
0245-0071Potassium Citratepotassium citrateUpsher-Smith Laboratories, LLCNDACurrent
44523-415Potassium Citratepotassium citrateBiocomp Pharma, Inc.NDA AUTHORIZED GENERICCurrent
44523-415Potassium Citratepotassium citrateBiocomp Pharma, Inc.NDA AUTHORIZED GENERICCurrent
44523-415Potassium Citratepotassium citrateBiocomp Pharma, Inc.NDA AUTHORIZED GENERICCurrent
44523-415Potassium Citratepotassium citrateBiocomp Pharma, Inc.NDA AUTHORIZED GENERICCurrent
70518-0086UROCIT-Kpotassium citrateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69576SUPPL2021-12-16
69550SUPPL2021-12-14
16186SUPPL2010-01-08
11432SUPPL2010-01-08