Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 008922
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIUM DISODIUM VERSENATE EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
CALCIUM DISODIUM VERSENATE EDETATE CALCIUM DISODIUM 500MG TABLET;ORAL Discontinued None No 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
07/16/1953 ORIG-1 Approval Type 1 - New Molecular Entity 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
06/17/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/21/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/19/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008922s016ltr.pdf
04/12/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/26/1996 SUPPL-14 Labeling

Label is not available on this site.

10/05/1992 SUPPL-13 Labeling

Label is not available on this site.

03/03/1992 SUPPL-12 Labeling

Label is not available on this site.

04/25/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/19/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.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