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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019708
Company: B BRAUN

Products on NDA 019708

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	37MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	75MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	110MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	220MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	300MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1989	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2026	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019708Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/019708Orig1s040ltr.pdf
08/22/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/31/2005	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019630s026,019708s016ltr.pdf
09/27/2004	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19708s013ltr.pdf
07/23/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/2002	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/12/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
05/04/1999	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/1998	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/21/1993	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/29/1991	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/1990	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/1990	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019708

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2026	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019708Orig1s040lbl.pdf
09/27/2004	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf

Therapeutic Equivalents for NDA 019708

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 150MG/100ML;900MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017648	BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212347	FRESENIUS KABI USA
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019708	B BRAUN

POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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