Application 021670

Type: NDA
Sponsor: DORC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VISIONBLUE	TRYPAN BLUE	SOLUTION;OPHTHALMIC	0.06%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021670-001	VISIONBLUE	TRYPAN BLUE	0.06%	SOLUTION / OPHTHALMIC		RLD, RS	2004-12-16

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021670-001	VISIONBLUE	0.06%	SOLUTION / OPHTHALMIC	RLD, RS	2004-12-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021670-001	6720314	2019-05-07	U-2321	2018-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021670-001	6367480	2019-10-26	U-2321	2018-06-21	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021670-001	6720314	2019-05-07	U-2321	2018-06-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021670-001	6367480	2019-10-26	U-2321	2018-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021670-001	6720314	2019-05-07	U-2321	2018-06-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021670-001	6367480	2019-10-26	U-2321	2018-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021670-001	6720314	2019-05-07	U-2321	2018-06-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021670-001	6367480	2019-10-26	U-2321	2018-06-21	`ea99ee380514…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VISIONBLUE	TRYPAN BLUE	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	a44bc2ef-3d7f-4125-a7f7-c5969b1b4142	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021670 application number: NDA021670 ndc (product): 68803-612

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68803-612	VISIONBLUE	Trypan Blue	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	NDA	Current
68803-612	VISIONBLUE	Trypan Blue	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	NDA	Current
68803-612	VISIONBLUE	Trypan Blue	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	NDA	Current
68803-612	VISIONBLUE	Trypan Blue	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77085	SUPPL	2023-12-19
77048	SUPPL	2023-12-19
37429	SUPPL	2012-11-28
5953	SUPPL	2012-11-23
21774	ORIG	2005-03-08
28341	ORIG	2004-12-30
15952	ORIG	2004-12-30