FDA.reportPublic FDA data

Application 021524

Type
NDA
Sponsor
PROF DSPLS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREVANTICS SWABCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL3.15%;70% (1ML)YesYes
002PREVANTICS SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL3.15%;70% (1.6ML)YesYes
003PREVANTICS MAXI SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOLSWAB;TOPICAL3.15%;70% (5.1ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl AlcoholProfessional Disposables International, Inc.NDACurrent
10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl AlcoholProfessional Disposables International, Inc.NDACurrent
10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl AlcoholProfessional Disposables International, Inc.NDACurrent
10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl AlcoholProfessional Disposables International, Inc.NDACurrent
10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl AlcoholProfessional Disposables International, Inc.NDACurrent
10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl AlcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4076Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4076Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4076Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4077Prevantics Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent
10819-4077Prevantics Swabstickchlorhexidine gluconate and isopropyl alcoholProfessional Disposables International, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69811SUPPL2022-01-05
68687SUPPL2021-09-21
57308SUPPL2019-01-22
57293SUPPL2019-01-22
52641SUPPL2018-02-14
49810SUPPL2017-09-20
49726SUPPL2017-09-13
37150SUPPL2014-07-29
5636SUPPL2014-07-28
15683SUPPL2014-03-26
5635SUPPL2014-03-26
5634SUPPL2012-05-18
5633SUPPL2012-03-05
37149SUPPL2007-10-22
28022SUPPL2007-10-22
21713ORIG2007-07-18
15682SUPPL2007-03-23
5632SUPPL2007-03-23
15681ORIG2005-06-07
5631ORIG2005-06-07