Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071910
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
02/28/1989 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/29/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
SODIUM IODIDE I 123
CAPSULE;ORAL; 200uCi
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE;ORAL | Prescription | Yes | AA | 018671 | CARDINAL HEALTH 418 |
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE;ORAL | Prescription | No | AA | 071910 | CURIUM |