FDA.reportPublic FDA data

Application 021400

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVITRAVARDENAFIL HYDROCHLORIDETABLET;ORAL5MGYesNo
002LEVITRAVARDENAFIL HYDROCHLORIDETABLET;ORAL10MGYesNo
003LEVITRAVARDENAFIL HYDROCHLORIDETABLET;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004LEVITRAVARDENAFIL HYDROCHLORIDETABLET;ORAL20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0829Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0829Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0829Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0829Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0830Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0830Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0830Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0830Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0830Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0831Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0831Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0831Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0831Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0831Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0831Levitravardenafil hydrochlorideGlaxoSmithKline LLCNDACurrent
43353-323Levitravardenafil hydrochlorideAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.NDACurrent
43353-741Levitravardenafil hydrochlorideAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.NDACurrent
43353-744Levitravardenafil hydrochlorideAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.NDACurrent
43353-748Levitravardenafil hydrochlorideAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.NDACurrent
55289-193Levitravardenafil hydrochloridePD-Rx Pharmaceuticals, InNDACurrent
55289-193Levitravardenafil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-193Levitravardenafil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
63629-3372Levitravardenafil hydrochlorideBryant Ranch PrepackNDACurrent
67544-507Levitravardenafil hydrochlorideAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.NDACurrent
67544-512Levitravardenafil hydrochlorideAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73777SUPPL 2023-03-16
49570SUPPL2017-08-29
49447SUPPL2017-08-17
15370SUPPL2015-09-23
27673SUPPL2015-09-17
15369SUPPL2014-05-02
27672SUPPL2014-04-30
15368SUPPL2013-08-06
27671SUPPL2013-08-05
15367SUPPL2011-11-30
27670SUPPL2011-11-28
5257SUPPL2008-05-21
5256SUPPL2008-03-21
15366SUPPL2008-03-20
5255SUPPL2007-10-22
44121ORIG2007-10-18
36821SUPPL2007-10-18
5254SUPPL2007-04-20
15365SUPPL2007-04-09
5253SUPPL2005-07-15
36820SUPPL2005-07-08
27669SUPPL2005-05-17
15364SUPPL2005-05-17
21637ORIG2003-10-29
36819ORIG2003-08-28
5252ORIG2003-08-28