Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016847
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
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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 |
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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 |
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02/15/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/01/1978 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/10/1977 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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09/14/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/21/1975 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/26/1976 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |