Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013132
Company: WOODWARD SPECL
Company: WOODWARD SPECL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECA-DURABOLIN | NANDROLONE DECANOATE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DECA-DURABOLIN | NANDROLONE DECANOATE | 100MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DECA-DURABOLIN | NANDROLONE DECANOATE | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/05/1962 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 05/20/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/10/1987 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/05/1984 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |