Application 202832

Type: NDA
Sponsor: MEDEFIL INC

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 (9MG/ML)	Yes	No
002	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	18MG/2ML (9MG/ML)	Yes	No
003	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	22.5MG/2.5ML (9MG/ML)	Yes	No
004	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	27MG/3ML (9MG/ML)	Yes	No
005	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	45MG/5ML (9MG/ML)	Yes	No
006	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	90MG/10ML (9MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N202832-001	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06
N202832-002	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06
N202832-003	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06
N202832-004	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06
N202832-005	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06
N202832-006	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06

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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202832-005	SODIUM CHLORIDE 0.9%	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202832-006	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202832-005	SODIUM CHLORIDE 0.9%	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202832-006	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202832-005	SODIUM CHLORIDE 0.9%	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202832-006	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202832-005	SODIUM CHLORIDE 0.9%	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202832-006	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202832-005	SODIUM CHLORIDE 0.9%	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202832-006	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202832-005	SODIUM CHLORIDE 0.9%	45MG/5ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202832-006	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	INJECTABLE / INJECTION	RLD, RS	2012-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202832-001	SODIUM CHLORIDE 0.9%	9MG/ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202832-002	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202832-003	SODIUM CHLORIDE 0.9%	22.5MG/2.5ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202832-004	SODIUM CHLORIDE 0.9%	27MG/3ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2012-01-06	`2680178bc6a6…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sodium chloride	SODIUM CHLORIDE	Medefil, Inc.	d1468c0f-dd4f-4d38-a84c-c1d110303965	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202832 application number: NDA202832 ndc (product): 64253-202

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64253-202	sodium chloride	SODIUM CHLORIDE	Medefil, Inc.	NDA	Current
64253-202	sodium chloride	SODIUM CHLORIDE	Medefil, Inc.	NDA	Current
64253-202	sodium chloride	SODIUM CHLORIDE	Medefil, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72499	SUPPL	2022-10-31
72489	SUPPL	2022-10-28
50564	SUPPL	2017-12-01
43415	ORIG	2012-10-25
10117	SUPPL	2012-10-02
40228	SUPPL	2012-09-28
32319	ORIG	2012-01-10