Application 022305

Type: NDA
Sponsor: NIAGARA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PUR-WASH	PURIFIED WATER	SOLUTION;OPHTHALMIC	98.3%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022305-001	PUR-WASH	PURIFIED WATER	98.3%	SOLUTION / OPHTHALMIC		RLD, RS	2011-09-01

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`f41ea6bd6efb…`

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 78641-786
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 72745-101

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-7198	Eyewash	Water	Henry Schein, Inc.	NDA	Current
0404-7198	Eyewash	Water	Henry Schein, Inc.	NDA	Current
0404-7198	Eyewash	Water	Henry Schein, Inc.	NDA	Current
0924-0158	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0158	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0160	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0160	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0162	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0162	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0168	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0168	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
13985-609	Eyewash	Water	MWI	NDA	Current
13985-609	Eyewash	Water	MWI	NDA	Current
13985-609	Eyewash	Water	MWI	NDA	Current
17478-620	Eyewash	Water	Akorn	NDA	Current
17478-620	Eyewash	Water	Akorn	NDA	Current
17478-620	Eyewash	Water	Akorn, Inc.	NDA	Current
17478-620	Eyewash	Water	Akorn, Inc.	NDA	Current
44224-0160	Easy Care First Aid Eyewash	Water	Tender Corporation	NDA	Current
47682-197	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-197	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-197	Medi-First First Aid Eye Wash	Purified Water	Unifirst First Aid Corporation	NDA	Current
47682-198	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-198	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-198	Medi-First First Aid Eye Wash	Purified Water	Unifirst First Aid Corporation	NDA	Current
47682-410	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-410	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-410	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-412	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-412	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-412	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-936	Medi-First Plus First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-936	Medi-First Plus First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-936	Medi-First Plus First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
55305-115	AeroWash Eyewash	Eyewash Solution	Aero Healthcare US LLC	NDA	Current
59276-416	Real Eyewash	Eyewash	Oliver Landon Intl Inc.	NDA	Current
65785-160	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-162	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-164	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-166	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-168	Pur-Wash	Eyewash	Niagara Pharmaceuticals, Inc.	NDA	Current
65785-168	Pur-Wash	Eyewash	Niagara Pharmaceuticals, Inc.	NDA	Current
65785-169	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
68071-2234	EyeWash	EyeWash	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2234	EyeWash	EyeWash	NuCare Pharmaceuticals,Inc.	NDA	Current
68599-1981	Eye wash	Purified Water	McKesson	NDA	Current
68599-1981	Eye wash	Purified Water	McKesson	NDA	Current
70290-310	Firstep Firstflush	Eyewash	Encon Safety Products, Inc.	NDA	Current
70290-310	Firstep Firstflush	Eyewash	Encon Safety Products, Inc.	NDA	Current
71338-119	ECOLAB Eye Wash	Purified Water	ECOLAB Food Safety Specialties, Inc.	NDA	Current
71338-119	ECOLAB Eye Wash	Purified Water	ECOLAB Food Safety Specialties, Inc.	NDA	Current
71338-119	ECOLAB Eye Wash	Purified Water	ECOLAB Food Safety Specialties, Inc.	NDA	Current
72745-100	Dynamic Eyewash	Water	Dynamic Safety International	NDA	Current
72745-101	Dynamic Eyewash with Eyecup	Water	Dynamic Safety International	NDA	Current
73408-936	Crane Safety Eye Wash	water solution	Crane Safety LLC	NDA	Current
73408-936	Crane Safety Eye Wash	water solution	Crane Safety LLC	NDA	Current
73408-936	Crane Safety Eye Wash	water solution	Crane Safety LLC	NDA	Current
78641-786	Eyewash	Eyewash	Global Equipment Company	NDA	Current
81238-6708	Neutral-Eyes	Purified Water 98.3%	Western First Aid Safety	NDA	Current
81238-6708	Neutral-Eyes	Purified Water 98.3%	Western First Aid Safety	NDA	Current
81238-6708	Neutral-Eyes	Purified Water 98.3%	Western First Aid Safety	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84916	SUPPL	2026-02-05
82675	SUPPL	2025-06-27
44731	ORIG	2012-06-26
42482	ORIG	2012-06-26
29558	ORIG	2011-09-16