Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017968
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPO-TESTADIOL | ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE | 2MG/ML;50MG/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 |
|---|---|---|---|---|---|---|---|
| 06/13/1980 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/23/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/10/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/28/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/15/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |