An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018960
Company: HOSPIRA

Products on NDA 018960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUPRIC CHLORIDE IN PLASTIC CONTAINER	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018960

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/1986	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018960s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018960Orig1s029ltr.pdf
06/12/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/06/2003	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18960slr013ltr.pdf
02/16/2001	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/31/1999	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/03/2000	SUPPL-10	Labeling		Label is not available on this site.
01/22/1999	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/2001	SUPPL-8	Labeling		Label is not available on this site.
08/29/1996	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1997	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/10/1990	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
06/29/1987	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/09/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018960

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018960s029lbl.pdf

Therapeutic Equivalents for NDA 018960

CUPRIC CHLORIDE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 0.4MG COPPER/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	212071	EXELA PHARMA
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	216113	SOMERSET
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	217626	STIRA
CUPRIC CHLORIDE IN PLASTIC CONTAINER	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018960	HOSPIRA

Top