Application 019329

Type: NDA
Sponsor: ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	SODIUM CHLORIDE	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1987-04-22

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML	INJECTABLE / INJECTION	RLD	1987-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML	INJECTABLE / INJECTION	RLD	1987-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019329-001	SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`3a93d1ddd44b…`

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 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	d98bf9f7-30ec-4927-a577-cabad192cb18	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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