Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016783
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASCORAY IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM 52%;26% INJECTABLE;INJECTION 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
01/26/1971 ORIG-1 Approval Type 4 - New Combination 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
01/13/1995 SUPPL-29 Labeling

Label is not available on this site.

08/28/1992 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1992 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1990 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1989 SUPPL-25 Labeling

Label is not available on this site.

12/01/1989 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1985 SUPPL-22 Labeling

Label is not available on this site.

10/10/1989 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/03/1983 SUPPL-18 Labeling

Label is not available on this site.

06/16/1982 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-16 Labeling

Label is not available on this site.

01/25/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1978 SUPPL-14 Efficacy

Label is not available on this site.

03/13/2009 SUPPL-13 Labeling

Label is not available on this site.

05/14/1976 SUPPL-12 Labeling

Label is not available on this site.

05/10/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1975 SUPPL-8 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