FDA.reportPublic FDA data

Application 017386

Type
NDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZAROXOLYNMETOLAZONETABLET;ORAL2.5MGYesNo
002ZAROXOLYNMETOLAZONETABLET;ORAL5MGYesYes
003ZAROXOLYNMETOLAZONETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-2215metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2215metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2215metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2215metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2216metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2216metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2216metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2216metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2217metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2217metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2217metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0527-2217metolazonemetolazoneLannett Company, Inc.NDA AUTHORIZED GENERICCurrent
0904-6915metolazonemetolazoneMajor PharmaceuticalsNDA AUTHORIZED GENERICCurrent
0904-6915metolazonemetolazoneMajor PharmaceuticalsNDA AUTHORIZED GENERICCurrent
0904-6915metolazonemetolazoneMajor PharmaceuticalsNDA AUTHORIZED GENERICCurrent
0904-6916metolazonemetolazoneMajor PharmaceuticalsNDA AUTHORIZED GENERICCurrent
0904-6916metolazonemetolazoneMajor PharmaceuticalsNDA AUTHORIZED GENERICCurrent
43353-999MetolazonemetolazoneAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
60687-536MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-536MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-536MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-536MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-547MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-547MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-547MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-547MetolazoneMetolazoneAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
65580-643metolazonemetolazoneUpstate Pharma, LLCNDA AUTHORIZED GENERICCurrent
65580-644metolazonemetolazoneUpstate Pharma, LLCNDA AUTHORIZED GENERICCurrent
65580-645metolazonemetolazoneUpstate Pharma, LLCNDA AUTHORIZED GENERICCurrent
68151-2943ZaroxolynmetolazoneCarilion Materials ManagementNDACurrent
71610-142metolazonemetolazoneAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
76519-1166METOLAZONEMETOLAZONEH.J. Harkins Co., Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63976SUPPL2020-07-21
63894SUPPL2020-07-14
50646SUPPL2017-12-08
45781SUPPL2016-11-02
45780SUPPL2016-11-02
13126SUPPL2003-08-25
33257SUPPL2003-06-16
572SUPPL2002-10-29