Home Applications 204630 Application 204630
Type NDA
Sponsor PROVEPHARM SAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROVAYBLUE METHYLENE BLUE SOLUTION;INTRAVENOUS 50MG/10ML (5MG/ML) Yes Yes 002 PROVAYBLUE METHYLENE BLUE SOLUTION;INTRAVENOUS 10MG/2ML (5MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204630-001 PROVAYBLUE METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 N204630-002 PROVAYBLUE METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N204630-001 M-303 2027-01-08 N204630-002 M-303 2027-01-08
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 80 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 74 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0125 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0371 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0371 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0371 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0371 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0374 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0381 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0381 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0381 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 0517-0381 PROVAYBLUE methylene blue American Regent, Inc. NDA Current 82454-0125 PROVAYBLUE methylene blue CENEXI HSC NDA Current 82454-0371 PROVAYBLUE methylene blue CENEXI HSC NDA Current 82454-0374 PROVAYBLUE methylene blue CENEXI HSC NDA Current 82454-0381 PROVAYBLUE methylene blue CENEXI HSC NDA Current