Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017316
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 | 50uCi | CAPSULE;ORAL | Discontinued | None | No | No |
SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 100uCi | CAPSULE;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 |
---|---|---|---|---|---|---|---|
11/09/1976 | 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. |