Application 088909

Type: ANDA
Sponsor: ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	No	No
002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	90MG/10ML (9MG/ML)	No	No

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

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
A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION / INJECTION			1985-02-07
A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION			1985-05-15

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 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	1985-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A088909-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	1985-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088909-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	1985-02-07	`5aa47cf7b7d7…`

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 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Hanlim	4ee80e16-1bb1-8238-e063-6294a90aa719	2026-04-04	Warnings	Name fallback generic name: SODIUM CHLORIDE
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	Hospira, Inc.	376093e7-e09e-4a57-3199-195e45251866	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Normal Salt	SODIUM CHLORIDE	TWIN MED LLC	10230c8a-e5e5-44f1-b41d-80930899d6b9	2026-03-31	Warnings	Name fallback generic name: SODIUM CHLORIDE
Worafy Gentle Eye Wash	SODIUM CHLORIDE	Shenzhen Shandian Jingling Technology Co., Ltd.	4da864dc-e10c-1db9-e063-6394a90a0984	2026-03-22	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE HYPERTONICITY	SODIUM CHLORIDE	YYBA CORP	439653b9-99b8-4799-8d67-4a2ada9c6783	2026-03-20	Warnings	Name fallback generic name: SODIUM CHLORIDE
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	e13fd053-9420-490c-a43e-e14b0930cb4e	2026-03-18	Warnings	Name fallback generic name: SODIUM CHLORIDE
RESP EASE	SODIUM CHLORIDE	Venture Healthcare Ltd	31b812c9-fb0a-5ee0-e063-6294a90a03e1	2026-03-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
RESP EASE	SODIUM CHLORIDE	Venture Healthcare Ltd	31b88e7c-eca0-5540-e063-6294a90a1b18	2026-03-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
RESP EASE	SODIUM CHLORIDE	Venture Healthcare Ltd	31b8c3f4-e528-c69d-e063-6294a90a5a34	2026-03-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
RESP EASE	SODIUM CHLORIDE	Laboratoire Unither	31b7eb13-39c3-6f0e-e063-6394a90a4011	2026-03-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
RESP EASE	SODIUM CHLORIDE	Laboratoire Unither	31b8bb9c-d30f-152f-e063-6394a90a5208	2026-03-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
RESP EASE	SODIUM CHLORIDE	Laboratoire Unither	31b8dcbd-9e6b-1edc-e063-6394a90aac73	2026-03-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	018a8807-1331-41c3-4889-c7ec502a9043	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Oimmal Gentle Eye Wash	SODIUM CHLORIDE	Shenzhen Shandian Jingling Technology Co., Ltd.	4bb4e59b-a43e-fa38-e063-6294a90aea71	2026-02-26	Warnings	Name fallback generic name: SODIUM CHLORIDE
sodium chloride	SODIUM CHLORIDE	Medefil, Inc.	d1468c0f-dd4f-4d38-a84c-c1d110303965	2026-02-26	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
0.9 percentsaline	SODIUM CHLORIDE	Huizhou Jinsheng Medical Technology Co., Ltd	487cb4fc-2e0b-020f-e063-6294a90a4526	2026-02-03	Warnings	Name fallback generic name: SODIUM CHLORIDE
0.9saline	SODIUM CHLORIDE	Huizhou Jinsheng Medical Technology Co., Ltd	49e76aca-ca2b-3b95-e063-6394a90a875e	2026-02-03	Warnings	Name fallback generic name: SODIUM CHLORIDE
0.9%saline	SODIUM CHLORIDE	Huizhou Jinsheng Medical Technology Co., Ltd	49e7b329-e4e5-6991-e063-6294a90ac817	2026-02-03	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Nephron Pharmaceuticals Corporation	a4edf2d5-a9ff-30d4-e053-2995a90a5650	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	ProPharma Distribution	48d73434-e65b-dc98-e063-6294a90affa2	2026-01-20	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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