Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011891
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DURABOLIN | NANDROLONE PHENPROPIONATE | 25MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DURABOLIN | NANDROLONE PHENPROPIONATE | 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 |
|---|---|---|---|---|---|---|---|
| 10/30/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 02/18/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1987 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/20/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/07/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/19/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |