Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019718
Company: B BRAUN

Products on NDA 019718

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOLYTE E IN PLASTIC CONTAINER	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	35MG/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019718

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
07/01/2002	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/15/2002	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/07/2000	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/21/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/26/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/13/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/21/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/29/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/12/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/21/1990	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/18/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.