Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010423
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORFAN | LEVALLORPHAN TARTRATE | 1MG/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 |
|---|---|---|---|---|---|---|---|
| 04/30/1956 | 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 |
|---|---|---|---|---|---|
| 04/19/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/11/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |