FDA.reportPublic FDA data

Application 018238

Type
NDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICRO-KPOTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL8MEQYesNo
002MICRO-K 10POTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MEQYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7646potassium chloridepotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDA AUTHORIZED GENERICCurrent
0615-7694potassium chloridepotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDA AUTHORIZED GENERICCurrent
51477-001potassium chloridepotassium chlorideNesher Pharmaceuticals (USA) LLCNDA AUTHORIZED GENERICCurrent
51477-002potassium chloridepotassium chlorideNesher Pharmaceuticals (USA) LLCNDA AUTHORIZED GENERICCurrent
68084-419potassium chloridepotassium chlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68382-701POTASSIUM CHLORIDEpotassium chlorideZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent
68382-701POTASSIUM CHLORIDEpotassium chlorideZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent
68382-701POTASSIUM CHLORIDEpotassium chlorideZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent
68382-702POTASSIUM CHLORIDEpotassium chlorideZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent
68382-702POTASSIUM CHLORIDEpotassium chlorideZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent
68382-702POTASSIUM CHLORIDEpotassium chlorideZydus Pharmaceuticals (USA) Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53987SUPPL2018-05-03
53979SUPPL2018-05-02
40787SUPPL2009-01-12
40786SUPPL2009-01-12
14953SUPPL2003-08-25