Drugs@FDA: FDA-Approved Drugs
Company: QUAGEN
| 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 |
|---|---|---|---|---|---|---|---|
| 07/23/1971 | 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 |
|---|---|---|---|---|---|
| 03/18/2021 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2020 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2016 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2016 | SUPPL-39 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/22/2011 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2010 | SUPPL-36 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 11/21/2002 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1995 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/31/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
PROPYLTHIOURACIL
There are no Therapeutic Equivalents.