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 9 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ed8fd0c1-ac42-4267-877e-ceadf3831c90	2021-04-29	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	c3f8e83c-4fb9-91da-e053-2a95a90abd63	2021-04-12	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
CVS Health Sterile Saline Mist Live Better	SODIUM CHLORIDE	CVS Pharmacy	ccc3ab8c-b22f-420d-869b-f2a65b8c7180	2021-03-13	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	aeaed9cb-b629-4019-88d2-a916179427de	2021-02-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Asclemed USA, Inc.	a411c118-ef0e-4c42-9924-4a06ec690e94	2021-01-14	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ac0fd44a-3f39-8d7e-e053-2995a90afeec	2020-08-04	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
WinCo Foods Saline Nasal Relief	SODIUM CHLORIDE	WinCo Foods, LLC	1280fee4-e763-49ba-8722-8cdb8157f1a4	2018-08-02	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	05dee566-7b82-4216-8a6b-765d2b4d9dc7	2018-07-17	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	181705c7-40e4-4d7d-b9ea-ada99380e7a9	2018-05-23	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	7c72520e-de3c-493d-8aea-11933376d968	2018-04-02	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	886f889b-f3cf-4197-b307-6cfa88c89436	2017-05-04		Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		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