Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016403
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYPAQUE DIATRIZOATE MEGLUMINE 60% INJECTABLE;INJECTION Discontinued None No No
HYPAQUE DIATRIZOATE MEGLUMINE 30% INJECTABLE;INJECTION Discontinued None No No
HYPAQUE-CYSTO DIATRIZOATE MEGLUMINE 30% SOLUTION;URETHRAL 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
08/21/1969 ORIG-1 Approval Type 3 - New Dosage Form 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
09/30/2002 SUPPL-71 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16403slr071ltr.pdf
08/13/2001 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1998 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

06/15/1995 SUPPL-68 Labeling

Label is not available on this site.

03/25/1994 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-66 Labeling

Label is not available on this site.

10/03/1991 SUPPL-65 Labeling

Label is not available on this site.

10/03/1991 SUPPL-64 Labeling

Label is not available on this site.

04/24/1991 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1989 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1989 SUPPL-61 Labeling

Label is not available on this site.

05/26/1989 SUPPL-60 Labeling

Label is not available on this site.

05/19/1989 SUPPL-59 Labeling

Label is not available on this site.

04/18/1989 SUPPL-58 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/1989 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

06/22/1989 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/11/1989 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-54 Labeling

Label is not available on this site.

02/26/1990 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

02/10/1986 SUPPL-52 Labeling

Label is not available on this site.

11/22/1985 SUPPL-51 Labeling

Label is not available on this site.

04/16/1985 SUPPL-50 Labeling

Label is not available on this site.

04/23/1985 SUPPL-49 Labeling

Label is not available on this site.

04/19/1985 SUPPL-48 Labeling

Label is not available on this site.

11/26/1984 SUPPL-47 Labeling

Label is not available on this site.

05/23/1988 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1983 SUPPL-45 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/14/1985 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1982 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

03/12/1984 SUPPL-42 Labeling

Label is not available on this site.

09/11/1985 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1983 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1982 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/1984 SUPPL-38 Labeling

Label is not available on this site.

01/24/1984 SUPPL-37 Efficacy

Label is not available on this site.

02/24/1982 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1984 SUPPL-35 Labeling

Label is not available on this site.

01/18/1982 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1983 SUPPL-33 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/11/1981 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/27/1981 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/17/1979 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/15/1979 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/15/1979 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1979 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/30/1978 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/30/1978 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/30/1978 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/28/1978 SUPPL-23 Efficacy

Label is not available on this site.

04/01/1977 SUPPL-22 Labeling

Label is not available on this site.

06/02/1976 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/02/1976 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/02/1976 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/25/1976 SUPPL-18 Labeling

Label is not available on this site.

06/21/1976 SUPPL-17 Labeling

Label is not available on this site.

08/22/1975 SUPPL-12 Labeling

Label is not available on this site.

05/29/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1975 SUPPL-9 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