Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019844
Company: B BRAUN

Products on NDA 019844

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	5GM/100ML;30MG/100ML;97MG/100ML;220MG/100ML;140MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019844

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/1993	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
05/14/2004	SUPPL-10	Labeling		Label is not available on this site.
07/01/2002	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/15/2002	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/07/2000	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/21/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/26/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/13/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/01/1994	SUPPL-1	Labeling		Label is not available on this site.