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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204630
Company: PROVEPHARM SAS

Summary Review

Products on NDA 204630

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROVAYBLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
PROVAYBLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204630

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204630s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204630Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204630Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204630Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204630Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204630Orig1s023ltr.pdf
11/02/2023	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204630s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204630Orig1s022ltr.pdf
01/08/2024	SUPPL-21	Efficacy-Accelerated Approval, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204630s021lbl.pdf
08/18/2022	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204630Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204630Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204630Orig1s018ltr.pdf
07/13/2022	SUPPL-16	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204630Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204630Orig1s016ltr.pdf
05/26/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204630s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204630Orig1s011ltr.pdf
05/21/2021	SUPPL-10	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204630Orig1s010ltr.pdf
12/03/2021	SUPPL-8	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204630Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204630Orig1s008ltr.pdf
05/21/2018	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204630s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204630Orig1s006ltr.pdf
12/29/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204630s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204630Orig1s005ltr.pdf
11/29/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204630

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204630Orig1s023lbl.pdf
01/08/2024	SUPPL-21	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204630s021lbl.pdf
01/08/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204630s021lbl.pdf
11/02/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204630s022lbl.pdf
08/18/2022	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204630Orig1s018lbl.pdf
07/13/2022	SUPPL-16	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204630Orig1s016lbl.pdf
12/03/2021	SUPPL-8	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204630Orig1s008lbl.pdf
05/26/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204630s011lbl.pdf
05/21/2018	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204630s006lbl.pdf
12/29/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204630s005lbl.pdf
04/08/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204630s000lbl.pdf

Therapeutic Equivalents for NDA 204630

PROVAYBLUE

SOLUTION;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215636	ZYDUS
PROVAYBLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204630	PROVEPHARM SAS

SOLUTION;INTRAVENOUS; 10MG/2ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLENE BLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215636	ZYDUS
PROVAYBLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204630	PROVEPHARM SAS

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