FDA.reportPublic FDA data

Application 090141

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-786TadalafilTadalafilAvkareANDACurrent
42291-786TadalafilTadalafilAvkareANDACurrent
42291-787TadalafilTadalafilAvKARE, Inc.ANDACurrent
42291-787TadalafilTadalafilAvKAREANDACurrent
42291-788TadalafilTadalafilAvKAREANDACurrent
42291-788TadalafilTadalafilAvKARE, Inc.ANDACurrent
42291-789TadalafilTadalafilAvKARE, Inc.ANDACurrent
42291-789TadalafilTadalafilAvKAREANDACurrent
71205-418TadalafilTadalafilProficient Rx LPANDACurrent
71610-353TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-354TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
76519-1225TADALAFILTADALAFILH.J. Harkins Company, Inc.ANDACurrent
76519-1226TADALAFILTADALAFILH.J. Harkins Company, Inc.ANDACurrent
76519-1227TADALAFILTADALAFILH.J. Harkins Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54440ORIG2018-06-05
50724ORIG2017-12-18