Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086029
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 100MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1978 | 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 |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-89 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/20/2015 | SUPPL-88 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-87 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-86 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-84 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-83 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-81 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/20/1993 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 07/16/1991 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 02/16/1990 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1986 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1982 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1982 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |