Application 019708

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	37MG/100ML;900MG/100ML	No	No
002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	75MG/100ML;900MG/100ML	No	No
003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	110MG/100ML;900MG/100ML	No	No
004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	150MG/100ML;900MG/100ML	No	No
005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	220MG/100ML;900MG/100ML	No	No
006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	300MG/100ML;900MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29
N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29
N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29
N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29
N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29
N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019708-004	AP

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 4 of 7 · 264 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
2019-12-13 00:20 UTC	2019-12	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019708-005	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	220MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019708-006	POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019708-001	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	37MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019708-002	POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019708-003	POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	110MG/100ML;900MG/100ML	INJECTABLE / INJECTION		1989-09-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019708-004	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	1989-09-29	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N019708-004	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019708-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019708-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019708-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019708-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019708-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019708-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019708-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019708-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019708-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019708-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019708-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019708-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019708-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019708-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019708-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019708-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019708-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019708-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019708-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019708-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019708-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019708-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019708-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019708-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019708-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019708-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019708-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019708-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019708-004	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019708-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019708-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019708-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019708-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019708-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019708-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019708-004	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019708-004	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019708-004	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019708-004	AP	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE IN SODIUM CHLORIDE	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	ecc38772-246a-46c4-b42a-b9b81124f27f	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019708 application number: NDA019708 ndc (product): 0264-7865

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-7865	POTASSIUM CHLORIDE IN SODIUM CHLORIDE	SODIUM CHLORIDE and POTASSIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7865	POTASSIUM CHLORIDE IN SODIUM CHLORIDE	SODIUM CHLORIDE and POTASSIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7865	POTASSIUM CHLORIDE IN SODIUM CHLORIDE	SODIUM CHLORIDE and POTASSIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84824	SUPPL	2026-01-22
84823	SUPPL	2026-01-22
19110	SUPPL	2005-09-08
19109	SUPPL	2004-09-29
11642	SUPPL	2004-09-29