Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018960
Company: HOSPIRA
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 None Yes Yes
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
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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English