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 3 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	Fresenius Kabi USA, LLC	d98bf9f7-30ec-4927-a577-cabad192cb18	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS Pharmacy	9245d842-7f78-42d8-83ba-8eb9ec8dbc0d	2026-01-15	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS PHARMACY	d5cc6cd1-ddf8-4f5b-a021-204cdda0db94	2026-01-15	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	BECTON DICKINSON AND COMPANY	d39b7307-df67-4e68-acb0-2eda5dc61215	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Normal Salt	SODIUM CHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	f3f09817-8a38-4aa1-956b-69d9cf695074	2025-12-25	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	ProPharma Distribution	3f79fb8b-d0e8-db2a-e063-6394a90ac136	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Rhinomel Manuka	SODIUM CHLORIDE	Melcare Biomedical Pty Ltd	35a7ce7d-4a26-e3f0-e063-6294a90ad66f	2025-12-09	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	SOLA Pharmaceuticals, LLC	4d0bfd28-460a-48ba-bd17-cf75e56d62f4	2025-12-09	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sterile Saline Mist Meijer	SODIUM CHLORIDE	Meijer, Inc.	445c8f4f-0519-0764-e063-6294a90a8b39	2025-12-01	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Walgreen Company	d112a344-33cc-41d3-bae6-492631ebdba7	2025-11-19	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ce0c8c6f-734a-400f-9b60-a3b1e263f25f	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Hospira, Inc.	af6aebad-ef03-4d19-9a40-18e5a278b812	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Henry Schein, Inc.	2e81ffca-05c6-4fa0-8911-4b3cbfa71351	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Rising Pharma Holdings, Inc.	42870188-b1d7-4934-a6c0-310530497dac	2025-11-07	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	d8b8d796-bfba-42af-a859-99d776871558	2025-11-07	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	3cfdeee0-ff14-4341-8396-b11c2a037c60	2025-11-02	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	5f372b75-d7a4-471e-8ac6-290040fc84b0	2025-11-02	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	009bef3c-e8ac-46be-b564-a2556adf0081	2025-10-31	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.

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