Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017315
Company: CIS
Company: CIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 50mCi/ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 11/16/1976 | 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 |
|---|---|---|---|---|---|
| 03/05/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/05/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |