Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017471
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM PERTECHNETATE TC 99M | TECHNETIUM TC-99M SODIUM PERTECHNETATE | 2-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INJECTION, ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/18/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 01/22/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1983 | SUPPL-8 | Efficacy |
Label is not available on this site. |
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| 02/21/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/17/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |