Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018874
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIJEX CALCITRIOL 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
CALCIJEX CALCITRIOL 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/25/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018874s022ltr.pdf
07/01/2007 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018874s019_ltr.pdf
11/16/2001 SUPPL-16 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18874s16ltr.pdf
05/07/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/2001 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/15/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1999 SUPPL-12 Labeling

Label is not available on this site.

05/26/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-10 Labeling

Label is not available on this site.

12/31/1997 SUPPL-9 Labeling

Label is not available on this site.

06/10/1997 SUPPL-8 Labeling

Label is not available on this site.

10/22/1996 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

01/05/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1990 SUPPL-2 Labeling

Label is not available on this site.

07/25/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf

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