Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076350
Company: BTG INTL
Company: BTG INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THYROSAFE | POTASSIUM IODIDE | 65MG | TABLET;ORAL | Over-the-counter | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/10/2002 | 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 |
|---|---|---|---|---|---|
| 02/13/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/21/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/30/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
THYROSAFE
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 |