Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018664
Company: ANBEX
Company: ANBEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IOSAT | POTASSIUM IODIDE | 130MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
| IOSAT | POTASSIUM IODIDE | 65MG | TABLET;ORAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 10/14/1982 | 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 |
|---|---|---|---|---|---|
| 12/20/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2011 | SUPPL-13 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 01/14/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/04/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
IOSAT
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 65MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| IOSAT | POTASSIUM IODIDE | 65MG | TABLET;ORAL | Over-the-counter | Yes | 018664 | ANBEX |
| THYROSAFE | POTASSIUM IODIDE | 65MG | TABLET;ORAL | Over-the-counter | No | 076350 | BTG INTL |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 130MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| IOSAT | POTASSIUM IODIDE | 130MG | TABLET;ORAL | Over-the-counter | Yes | 018664 | ANBEX |