FDA.reportPublic FDA data

Application 204630

Type
NDA
Sponsor
PROVEPHARM SAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROVAYBLUEMETHYLENE BLUESOLUTION;INTRAVENOUS50MG/10ML (5MG/ML)YesYes
002PROVAYBLUEMETHYLENE BLUESOLUTION;INTRAVENOUS10MG/2ML (5MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0125PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0371PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0371PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0371PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0371PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0374PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0381PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0381PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0381PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
0517-0381PROVAYBLUEmethylene blueAmerican Regent, Inc.NDACurrent
82454-0125PROVAYBLUEmethylene blueCENEXI HSCNDACurrent
82454-0371PROVAYBLUEmethylene blueCENEXI HSCNDACurrent
82454-0374PROVAYBLUEmethylene blueCENEXI HSCNDACurrent
82454-0381PROVAYBLUEmethylene blueCENEXI HSCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81569SUPPL 2025-03-14
80481SUPPL 2024-12-03
80164SUPPL 2024-11-05
77418SUPPL 2024-03-04
77407SUPPL 2024-02-07
77199SUPPL 2024-01-09
76225SUPPL 2023-11-07
76218SUPPL 2023-11-03
71856SUPPL2022-08-23
71852SUPPL2022-08-19
71850SUPPL2022-08-19
71766SUPPL2022-08-10
71751SUPPL2022-08-09
71516SUPPL2022-07-05
71515SUPPL2022-07-05
67658SUPPL2021-06-02
67621SUPPL2021-05-28
67575SUPPL2021-05-24
54326SUPPL2018-05-24
54310SUPPL2018-05-23
50950SUPPL2018-01-02
50979SUPPL2017-12-29
47192ORIG2017-02-13
47191ORIG2017-02-13
19582ORIG2016-04-12
10370ORIG2016-04-12