Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016847
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOPAQUE 440 CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM 0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML 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
11/17/1973 ORIG-1 Approval Type 2 New Active Ingredient and Type 4 New Combination 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
02/15/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/14/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1977 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/14/1977 SUPPL-4 Labeling

Label is not available on this site.

11/21/1975 SUPPL-3 Labeling

Label is not available on this site.

03/26/1976 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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