Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008032
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TELEPAQUE IOPANOIC ACID 500MG TABLET;ORAL 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
07/16/1951 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
05/02/1990 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1987 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1986 SUPPL-21 Labeling

Label is not available on this site.

11/23/1985 SUPPL-20 Labeling

Label is not available on this site.

04/19/1985 SUPPL-19 Labeling

Label is not available on this site.

03/14/1984 SUPPL-18 Labeling

Label is not available on this site.

09/30/1983 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1979 SUPPL-15 Labeling

Label is not available on this site.

10/12/1978 SUPPL-13 Labeling

Label is not available on this site.

10/15/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1976 SUPPL-11 Labeling

Label is not available on this site.

10/15/1976 SUPPL-10 Labeling

Label is not available on this site.

10/18/1976 SUPPL-9 Labeling

Label is not available on this site.

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