Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008032
Company: GE HEALTHCARE
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. |
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| 05/20/1987 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/01/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 11/23/1985 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/19/1985 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/14/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 09/30/1983 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/27/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 10/12/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 10/15/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/15/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/15/1976 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/18/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |