Application 216264

Type: NDA
Sponsor: PROVEPHARM SAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BLUDIGO	INDIGOTINDISULFONATE SODIUM	SOLUTION; INJECTION	40MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216264-001	BLUDIGO	INDIGOTINDISULFONATE SODIUM	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-07-08

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216264-001	11845867	2036-11-25	Drug substance	2024-01-11
N216264-001	10927258	2037-12-23	Drug substance	2022-08-01
N216264-001	11499050	2037-12-23	Drug substance	2022-11-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216264-001	NCE	2027-07-08

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216264-001	BLUDIGO	40MG/5ML (8MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-08	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 71 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216264-001	10927258	2037-12-23	Drug substance	2022-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216264-001	11499050	2037-12-23	Drug substance	2022-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216264-001	11845867	2036-11-25	Drug substance	2024-01-11	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N216264-001	NCE	2027-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216264-001	NCE	2027-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216264-001	NCE	2027-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216264-001	NCE	2027-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216264-001	NCE	2027-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216264-001	NCE	2027-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216264-001	NCE	2027-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216264-001	NCE	2027-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216264-001	NCE	2027-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216264-001	NCE	2027-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216264-001	NCE	2027-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216264-001	NCE	2027-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216264-001	NCE	2027-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216264-001	NCE	2027-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216264-001	NCE	2027-07-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216264-001	NCE	2027-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216264-001	NCE	2027-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216264-001	NCE	2027-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216264-001	NCE	2027-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216264-001	NCE	2027-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216264-001	NCE	2027-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216264-001	NCE	2027-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216264-001	NCE	2027-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216264-001	NCE	2027-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216264-001	NCE	2027-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216264-001	NCE	2027-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216264-001	NCE	2027-07-08	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216264-001	NCE	2027-07-08	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bludigo	INDIGOTINDISULFONATE SODIUM	Sagent Pharmaceuticals	2b91c39d-5f15-4dcf-9d3d-b378470e6bd7	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216264 application number: NDA216264
BLUDIGO	INDIGOTINDISULFONATE SODIUM	Provepharm Inc.	73f246c4-b127-452e-856f-134b56cb8870	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216264 application number: NDA216264 ndc (product): 81284-315

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81284-315	BLUDIGO	indigotindisulfonate sodium	Provepharm Inc.	NDA	Current
81284-315	BLUDIGO	indigotindisulfonate sodium	Provepharm Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74275	ORIG	2023-05-17
74012	SUPPL	2023-04-17
74011	SUPPL	2023-04-17
71534	ORIG	2022-07-11
71533	ORIG	2022-07-11