Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011386
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYPAQUE DIATRIZOATE SODIUM 100% FOR SOLUTION;ORAL, RECTAL Discontinued None No No
HYPAQUE DIATRIZOATE SODIUM 40% SOLUTION;ORAL, RECTAL 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
03/26/1956 ORIG-1 Approval Type 3 - New Dosage Form 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
09/30/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/15/1995 SUPPL-33 Labeling

Label is not available on this site.

08/23/1996 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/01/1990 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/01/1990 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/09/1988 SUPPL-27 Labeling

Label is not available on this site.

08/02/1988 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/17/1986 SUPPL-24 Labeling

Label is not available on this site.

02/10/1986 SUPPL-23 Labeling

Label is not available on this site.

12/28/1984 SUPPL-22 Labeling

Label is not available on this site.

09/12/1984 SUPPL-21 Labeling

Label is not available on this site.

05/29/1991 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/1982 SUPPL-16 Labeling

Label is not available on this site.

01/12/1984 SUPPL-15 Labeling

Label is not available on this site.

07/05/1979 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/13/1977 SUPPL-13 Labeling

Label is not available on this site.

09/29/1976 SUPPL-11 Labeling

Label is not available on this site.

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