Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086505
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYPAQUE-76 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 66%;10% 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
07/02/1980 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2001 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/19/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/19/1996 SUPPL-18 Labeling

Label is not available on this site.

06/16/1995 SUPPL-17 Labeling

Label is not available on this site.

10/11/1991 SUPPL-16 Labeling

Label is not available on this site.

01/23/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/24/1989 SUPPL-14 Labeling

Label is not available on this site.

01/29/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/29/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/02/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/27/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/27/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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