Cupric Chloride In Plastic Container

NDA 18960, held by Hospira. Cupric Chloride.

As of Nov 13, 2026, NDA 18960 (Cupric Chloride In Plastic Container), held by Hospira, was first approved by FDA on Jun 26, 1986, with 13 approved supplements and 0 published complete response letters.

First approved: Jun 26, 1986
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Copper (Cupric Chloride Injection) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cupric Chloride In Plastic ContainerEQ 0.4MG COPPER/ML · injectable;injection	Cupric Chloride	RxReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 9, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label
Jun 12, 2014	Supplement 21Manufacturing · Priority review	Approved	None posted
Mar 6, 2003	Supplement 13Labeling · Standard review	Approved	Letter
Aug 29, 2001	Supplement 8Labeling · Standard review	Approved	None posted
Feb 16, 2001	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 3, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Aug 31, 1999	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 22, 1999	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 17, 1997	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 29, 1996	Supplement 7Manufacturing · Priority review	Approved	None posted
May 10, 1990	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 29, 1987	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 9, 1986	Supplement 1Manufacturing · Priority review	Approved	None posted
Jun 26, 1986	Original applicationNew formulation or manufacturer · Priority review	Approved	None posted

Identifiers

Application: NDA 18960
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