Application 018469

Type: NDA
Sponsor: ALCON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BSS PLUS	CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE	SOLUTION;IRRIGATION	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	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
N018469-001	BSS PLUS	CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION		RLD, RS, Approved before 1982

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018469-001	BSS PLUS	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`cb3db0bc1861…`

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
BSS PLUS	BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE	Alcon Laboratories, Inc.	9b6d7322-4a90-b31e-9fbb-f1fba1343608	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018469 application number: NDA018469 ndc (product): 0065-0800
BSS PLUS	BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE	Alcon Laboratories, Inc.	f69655c5-cf32-6461-e00e-3a5c4a761344	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018469 application number: NDA018469 ndc (product): 0065-0800

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current
0065-0800	BSS PLUS	balanced salt solution enriched with bicarbonate, dextrose, and glutathione	Alcon Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73986	SUPPL	2023-04-14
11227	SUPPL	2016-06-17
932	SUPPL	2016-04-28
15013	SUPPL	2015-12-22
931	SUPPL	2015-12-22
33497	SUPPL	2015-11-12
11226	SUPPL	2015-11-12
11225	SUPPL	2015-05-14
33496	SUPPL	2004-12-30
11224	SUPPL	2004-12-30
930	SUPPL	2004-12-30
929	SUPPL	2004-12-30
33495	SUPPL	2004-05-27
33494	SUPPL	2004-05-27
15012	SUPPL	2004-05-27
928	SUPPL	2004-05-27
15011	SUPPL	2003-07-28
927	SUPPL	2003-07-28