Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container, Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container, Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container

Manages acute or chronic renal failure. NDA 20163, held by Vantive US Hlthcare. Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 13, 2026, NDA 20163 (Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container, Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container, Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container), held by Vantive US Hlthcare, was first approved by FDA on Dec 4, 1992, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 4, 1992
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. For management of acute or chronic renal failure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 4, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate	RxReference drug
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate	RxReference drug
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 5, 2023	Supplement 30Labeling · Standard review	Approved	Letter Label
Aug 16, 2016	Supplement 28Labeling · Standard review	Approved	Label Letter
Sep 1, 2015	Supplement 27Labeling · Standard review	Approved	Letter Label
Jun 5, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 9, 2015	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 30, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 26, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 9, 2005	Supplement 13Manufacturing · Standard review	Approved	Letter
Aug 9, 2005	Supplement 12Labeling · Standard review	Approved	Letter
Feb 12, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 22, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 22, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 9, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 1, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 4, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20163
Drugs@FDA: Overview at FDA
Company: Vantive US Healthcare

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