FDA.reportPublic FDA data

Application 018225

Type
NDA
Sponsor
VALIDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUMEXBUMETANIDETABLET;ORAL1MGYesNo
002BUMEXBUMETANIDETABLET;ORAL0.5MGYesNo
003BUMEXBUMETANIDETABLET;ORAL2MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-630BumexBumetanideValidus Pharmaceuticals LLCNDACurrent
30698-630BumexBumetanideValidus Pharmaceuticals LLCNDACurrent
30698-631BumexBumetanideValidus Pharmaceuticals LLCNDACurrent
30698-631BumexBumetanideValidus Pharmaceuticals LLCNDACurrent
30698-632BumexBumetanideValidus Pharmaceuticals LLCNDACurrent
30698-632BumexBumetanideValidus Pharmaceuticals LLCNDACurrent
42799-119BumetanideBumetanideEdenbridgeNDA AUTHORIZED Current
42799-119BumetanideBumetanideEdenbridge Pharmaceuticals LLC.NDA AUTHORIZED GENERICCurrent
42799-120BumetanideBumetanideEdenbridgeNDA AUTHORIZED Current
42799-120BumetanideBumetanideEdenbridge Pharmaceuticals LLC.NDA AUTHORIZED GENERICCurrent
42799-121BumetanideBumetanideEdenbridgeNDA AUTHORIZED Current
42799-121BumetanideBumetanideEdenbridge Pharmaceuticals LLC.NDA AUTHORIZED GENERICCurrent
50090-5064BumetanideBumetanideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5065BumetanideBumetanideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5068BumetanideBumetanideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
60687-384BumetanideBumetanideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-384BumetanideBumetanideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-384BumetanideBumetanideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-384BumetanideBumetanideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-535BumetanideBumetanideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-535BumetanideBumetanideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
63629-7440BumetanideBumetanideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7440BumetanideBumetanideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68071-3128BumetanideBumetanideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3128BumetanideBumetanideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-3191BumetanideBumetanideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71335-0016BumetanideBumetanideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0016BumetanideBumetanideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77596SUPPL 2024-02-22
77238SUPPL 2024-01-19
55275SUPPL2018-08-23
55159SUPPL2018-08-10
48316SUPPL2017-05-09
48252SUPPL2017-05-05
877SUPPL2010-01-26
11185SUPPL2010-01-24
14949SUPPL2003-06-08
40784SUPPL2003-03-07
20114SUPPL2003-03-07
33459SUPPL2002-10-29
14948SUPPL2002-10-29
11184SUPPL2002-10-29
876SUPPL2002-10-29