Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087750
Company: CHARTWELL
Company: CHARTWELL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIRILON | METHYLTESTOSTERONE | 10MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/24/1982 | 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 |
|---|---|---|---|---|---|
| 01/26/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/04/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/06/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |