Application 203352

Type: ANDA
Sponsor: JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	No	No
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	27MG/3ML (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
A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION			2016-05-18
A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	27MG/3ML (9MG/ML)	SOLUTION / INJECTION			2016-05-18

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203352-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	27MG/3ML (9MG/ML)	SOLUTION / INJECTION		2016-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION		2016-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION		2016-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION		2016-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	2016-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION		2016-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION		2016-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	2016-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203352-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	2016-05-18	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203352-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203352-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203352-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203352-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203352-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203352-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203352-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203352-001	AP	1	`ea99ee380514…`

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 4 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	97007188-43fe-416c-a87b-6ccc4d9ae2ec	2025-10-29	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Method Pharmaceuticals	ce84727a-3677-4bf0-e053-2995a90a3ec8	2025-10-21	Warnings	Name fallback generic name: SODIUM CHLORIDE
Walgreens	SODIUM CHLORIDE	Walgreen Company	21dfc2cf-65ae-c3fb-e063-6294a90a0a94	2025-10-17		Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ca3355f2-2cf0-4f58-bed5-0c4c0a7d3511	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
QUALITY CHOICE SALINE	SODIUM CHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f51491d8-12ad-4b1b-a171-c621bfdcc341	2025-08-12	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	e0466bb3-6c26-4044-b051-69f48b67f632	2025-08-07	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	9e72418a-376e-4637-99ad-d13c904a7986	2025-07-30	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	28f79c75-82d2-4912-81fc-a723b5ccf4c1	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	ProPharma Distribution	3868864f-4f46-d2a1-e063-6394a90a65d5	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	0d59a04a-32e6-485b-b638-a1e6c09e9642	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Normal Salt	SODIUM CHLORIDE	Twin Med LLC	dc82ff0f-8600-373a-e053-2995a90a7505	2025-07-03	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Advanced Rx LLC	40f471b7-27cf-4ad4-aef6-cc9d0623ddd9	2025-07-02	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	958d35f0-6834-43be-a700-fa58f38b4c19	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	6d43fa91-0940-437f-ba70-b2d3f977593e	2025-04-25	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Nat Mur 6X	SODIUM CHLORIDE	Hyland's Inc.	dcf0e2ac-3b69-3ae4-e053-2a95a90aaf41	2025-04-10	Warnings	Name fallback generic name: SODIUM CHLORIDE
HYDRA NEB	SODIUM CHLORIDE	Venture Healthcare Ltd	30b184bf-2451-d96b-e063-6294a90a43c7	2025-03-19	Warnings	Name fallback generic name: SODIUM CHLORIDE
HYDRA NEB	SODIUM CHLORIDE	Laboratoire Unither	30b244c0-84bb-a0a0-e063-6394a90a9dee	2025-03-19	Warnings	Name fallback generic name: SODIUM CHLORIDE
Natrum Muriaticum 6X	SODIUM CHLORIDE	SEVENE USA	ff0d279e-210a-6f8a-e053-6294a90a11dc	2025-02-11	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	aae783b2-18fe-69ca-e053-2a95a90a0800	2025-01-30	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	82c29f1d-a018-7483-e053-2a91aa0a8f7e	2025-01-30	Warnings	Name fallback generic name: SODIUM CHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65044-7131	sodium chloride	sodium chloride	Jubilant HollisterStier LLC	ANDA	Current
65044-7131	sodium chloride	sodium chloride	Jubilant HollisterStier LLC	ANDA	Current
65044-7133	sodium chloride	sodium chloride	Jubilant HollisterStier LLC	ANDA	Current
65044-7133	sodium chloride	sodium chloride	Jubilant HollisterStier LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32415	ORIG	2016-05-24