Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019395
Company: FRESENIUS MEDCL

Products on NDA 019395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE	25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100ML	SOLUTION;INTRAPERITONEAL	Discontinued	None	No	No
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE	25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100ML	SOLUTION;INTRAPERITONEAL	Discontinued	None	No	No
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE	25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100ML	SOLUTION;INTRAPERITONEAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/1986	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
09/27/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/03/1996	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/28/1992	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/10/1991	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/11/1990	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/22/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/26/1986	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.