Ocl

NDA 19284, held by Hospira. Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate.

As of Nov 13, 2026, NDA 19284 (Ocl), held by Hospira, was first approved by FDA on Apr 30, 1986, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1986
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Apr 30, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ocl6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML · solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2007	Supplement 9Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 11Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 13Labeling · Standard review	Approved	None posted
Aug 17, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 4, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 3, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 30, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 13, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 22, 1988	Supplement 5Labeling	Approved	None posted
Sep 30, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 30, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 25, 1987	Supplement 3Labeling	Approved	None posted
Apr 30, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19284
Drugs@FDA: Overview at FDA
Company: Hospira

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

Ocl