Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018550
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIMADYL | CARPROFEN | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| RIMADYL | CARPROFEN | 150MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/31/1987 | 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 |
|---|---|---|---|---|---|
| 02/27/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/17/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1989 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |