Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018719
Company: BIOENVISION
Company: BIOENVISION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MODRASTANE | TRILOSTANE | 60MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MODRASTANE | TRILOSTANE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1984 | 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 |
|---|---|---|---|---|---|
| 07/16/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/08/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 07/23/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |