An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
12/02/2024	SUPPL-26	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204630Orig1s026ltr.pdf
02/05/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204630Orig1s023correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204630Orig1s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/204630Orig1s023.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/2024/204630Orig1s023correctedlbl.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	217561	NEXUS
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216955	STERISCIENCE
METHYLENE BLUE	METHYLENE BLUE	50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215636	ZYDUS LIFESCIENCES
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 LIFESCIENCES
PROVAYBLUE	METHYLENE BLUE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204630	PROVEPHARM SAS

Top