Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPYLTHIOURACIL | PROPYLTHIOURACIL | 50MG | TABLET;ORAL | Prescription | BD | 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 |
|---|---|---|---|---|---|---|---|
| 01/09/1973 | 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 |
|---|---|---|---|---|---|
| 12/06/2019 | SUPPL-60 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2019 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/13/2011 | SUPPL-50 | REMS-Modified |
Label is not available on this site. |
||
| 10/11/2011 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2011 | SUPPL-48 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 12/15/2010 | SUPPL-46 | REMS-Proposal |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/2000 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/23/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
PROPYLTHIOURACIL
There are no Therapeutic Equivalents.