Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010220
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYPAQUE-M,75% DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 50%;25% INJECTABLE;INJECTION Discontinued None No No
HYPAQUE-M,90% DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 60%;30% 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
11/09/1955 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
03/25/1994 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/04/1990 SUPPL-45 Labeling

Label is not available on this site.

10/03/1991 SUPPL-44 Labeling

Label is not available on this site.

04/24/1991 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1989 SUPPL-42 Labeling

Label is not available on this site.

05/19/1989 SUPPL-41 Labeling

Label is not available on this site.

04/11/1989 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/26/1990 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/25/1986 SUPPL-38 Labeling

Label is not available on this site.

06/25/1986 SUPPL-37 Labeling

Label is not available on this site.

07/24/1985 SUPPL-36 Labeling

Label is not available on this site.

06/26/1985 SUPPL-35 Labeling

Label is not available on this site.

09/13/1984 SUPPL-34 Labeling

Label is not available on this site.

05/23/1988 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/30/1983 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1983 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1984 SUPPL-30 Labeling

Label is not available on this site.

02/17/1979 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/31/1978 SUPPL-28 Labeling

Label is not available on this site.

02/01/1978 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1978 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/31/1978 SUPPL-25 Labeling

Label is not available on this site.

04/08/1976 SUPPL-24 Labeling

Label is not available on this site.

01/26/1976 SUPPL-23 Labeling

Label is not available on this site.

01/21/1976 SUPPL-22 Labeling

Label is not available on this site.

01/21/1976 SUPPL-21

Label is not available on this site.

01/29/1974 SUPPL-17 Labeling

Label is not available on this site.

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