Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 009561
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYPAQUE DIATRIZOATE SODIUM 50% INJECTABLE;INJECTION Discontinued None No No
HYPAQUE DIATRIZOATE SODIUM 25% INJECTABLE;INJECTION Discontinued None No No
HYPAQUE SODIUM 20% DIATRIZOATE SODIUM 20% SOLUTION;URETERAL 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
11/26/1954 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
08/13/2001 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1998 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

06/15/1995 SUPPL-77 Labeling

Label is not available on this site.

08/23/1996 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1993 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-73 Labeling

Label is not available on this site.

10/03/1991 SUPPL-72 Labeling

Label is not available on this site.

10/03/1991 SUPPL-71 Labeling

Label is not available on this site.

06/29/1989 SUPPL-70 Labeling

Label is not available on this site.

05/26/1989 SUPPL-69 Labeling

Label is not available on this site.

05/02/1989 SUPPL-68 Labeling

Label is not available on this site.

04/11/1989 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-66 Labeling

Label is not available on this site.

08/24/1987 SUPPL-64 Labeling

Label is not available on this site.

11/07/1986 SUPPL-63 Labeling

Label is not available on this site.

02/26/1990 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

06/25/1986 SUPPL-61 Labeling

Label is not available on this site.

03/17/1986 SUPPL-60 Labeling

Label is not available on this site.

08/14/1986 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/26/1985 SUPPL-58 Labeling

Label is not available on this site.

04/19/1985 SUPPL-57 Labeling

Label is not available on this site.

05/23/1988 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1987 SUPPL-55 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/14/1985 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1982 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

08/03/1983 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1982 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/1987 SUPPL-48 Labeling

Label is not available on this site.

02/24/1982 SUPPL-47 Labeling

Label is not available on this site.

04/05/1984 SUPPL-46 Labeling

Label is not available on this site.

02/29/1984 SUPPL-45 Labeling

Label is not available on this site.

01/18/1982 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1986 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/11/1981 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/30/1982 SUPPL-40 Labeling

Label is not available on this site.

10/11/1979 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1979 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/15/1979 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1978 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1978 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/16/1977 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/06/1978 SUPPL-33 Labeling

Label is not available on this site.

02/23/1977 SUPPL-31 Labeling

Label is not available on this site.

09/08/1976 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/26/1976 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/02/1976 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/08/1976 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/26/1976 SUPPL-24 Labeling

Label is not available on this site.

06/02/1976 SUPPL-23 Labeling

Label is not available on this site.

02/11/1976 SUPPL-22 Labeling

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