FDA.reportPublic FDA data

Application 202276

Type
NDA
Sponsor
METUCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STENDRAAVANAFILTABLET;ORAL50MGYesNo
002STENDRAAVANAFILTABLET;ORAL100MGYesNo
003STENDRAAVANAFILTABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62541-501STENDRAAvanafilVivus LLCNDACurrent
62541-501STENDRAAvanafilVivus LLCNDACurrent
62541-502STENDRAAvanafilVivus LLCNDACurrent
62541-502STENDRAAvanafilVivus LLCNDACurrent
62541-503STENDRAAvanafilVivus LLCNDACurrent
62541-503STENDRAAvanafilVivus LLCNDACurrent
72384-751StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-751StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-751StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-751StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-752StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-752StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-752StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-752StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-753StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-753StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-753StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
72384-753StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
76299-320StendraavanafilMist Pharmaceuticals, LLCNDACurrent
76299-320StendraavanafilMist Pharmaceuticals, LLCNDACurrent
76299-320StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
76299-321StendraavanafilMist Pharmaceuticals, LLCNDACurrent
76299-321StendraavanafilMist Pharmaceuticals, LLCNDACurrent
76299-321StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent
76299-322StendraavanafilMist Pharmaceuticals, LLCNDACurrent
76299-322StendraavanafilMist Pharmaceuticals, LLCNDACurrent
76299-322StendraavanafilMetuchen Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72444SUPPL2022-10-21
72407SUPPL2022-10-19
55126SUPPL2018-08-07
55121SUPPL2018-08-06
50028SUPPL2017-10-12
50007SUPPL2017-10-11
49561SUPPL2017-08-29
49441SUPPL2017-08-17
40159SUPPL2015-09-23
10014SUPPL2015-09-17
40158SUPPL2015-06-05
32224SUPPL2015-05-19
40157SUPPL2014-09-19
10013SUPPL2014-09-18
19311SUPPL2014-05-02
32223SUPPL2014-04-30
40156SUPPL2012-11-06
10012SUPPL2012-11-06
22882ORIG2012-06-04
19310ORIG2012-04-27
10011ORIG2012-04-27