Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018722
Company: B BRAUN

Products on NDA 018722

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	75MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	220MG/100ML;900MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% 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 018722

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/1982	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
09/11/1990	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/24/1985	SUPPL-4	Labeling		Label is not available on this site.
04/03/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/03/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.