Inpersol-Zm W/ Dextrose 1.5% In Plastic Container, Inpersol-Zm W/ Dextrose 2.5% In Plastic Container, Inpersol-Zm W/ Dextrose 4.25% In Plastic Container

NDA 19395, held by Fresenius Medcl. Calcium Chloride; Dextrose; Sodium Chloride; Sodium Lactate.

As of Nov 13, 2026, NDA 19395 (Inpersol-Zm W/ Dextrose 1.5% In Plastic Container, Inpersol-Zm W/ Dextrose 2.5% In Plastic Container, Inpersol-Zm W/ Dextrose 4.25% In Plastic Container), held by Fresenius Medcl, was first approved by FDA on Mar 26, 1986, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1986
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 26, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Inpersol-Zm W/ Dextrose 1.5% In Plastic Container25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Sodium Chloride; Sodium Lactate	Discontinued
Inpersol-Zm W/ Dextrose 2.5% In Plastic Container25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Sodium Chloride; Sodium Lactate	Discontinued
Inpersol-Zm W/ Dextrose 4.25% In Plastic Container25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Sodium Chloride; Sodium Lactate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 27, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 3, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 26, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19395
Drugs@FDA: Overview at FDA
Company: Fresenius Medcl

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters