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SODIUM CHLORIDE	INJECTABLE;INJECTION	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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23.4% IN PLASTIC CONTAINER	SODIUM CHLORIDE	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1987-04-22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SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`c2088c7a36db…`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SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`84e616aacf4f…`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SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`caaa826d4ba7…`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SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER	234MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-04-22	`011fe1cb6892…`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 8 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	51da05ce-e3c4-4ef5-a845-dc869152e17f	2022-10-24	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sterile Saline Kids Mist PediaMeds	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5b580-1d9f-3081-e053-2995a90a8031	2022-08-08	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sterile Saline Kids Mist SinuCleanse Breathe	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5c313-046f-b0a7-e053-2a95a90a2a07	2022-08-08	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Wild Horse 777 Moisturizing Nasal	SODIUM CHLORIDE	Wild Horse 777, Inc.	b0b4dadd-11fa-3dbb-e053-2995a90a2097	2022-03-14	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	cc14fafd-3dcd-4fc8-bdbd-6f355c375768	2022-02-23	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	8b44bfd3-70a4-4b47-bc7b-590f63b8cc75	2022-02-15	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sterile Saline Mist Walgreens	SODIUM CHLORIDE	WALGREEN COMPANY	d6b9d4fc-b758-be32-e053-2995a90a2523	2022-01-29	Warnings	Name fallback generic name: SODIUM CHLORIDE
Extra Strenght Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID CORPORATION	d5b30fb2-4052-4a0c-e053-2a95a90aacd5	2022-01-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sterile Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID	d583067e-1133-7d7d-e053-2a95a90a1e36	2022-01-13	Warnings	Name fallback generic name: SODIUM CHLORIDE
SinuCleanse Sterile Saline Mist	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	648da2bc-bc91-4295-9e46-d3055cdc2418	2022-01-08	Warnings	Name fallback generic name: SODIUM CHLORIDE
SinuCleanse Nasal Drip	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	d5129a91-50e7-6b94-e053-2a95a90a2b30	2022-01-08	Warnings	Name fallback generic name: SODIUM CHLORIDE
SinuCleanse Sterile Saline Mist Daily Care	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	d5131ab2-8213-3659-e053-2a95a90ab2ab	2022-01-08	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4829ee40-c2d7-4e17-a606-75e8a8628413	2021-12-21	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	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.