Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012542
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TANDEARIL | OXYPHENBUTAZONE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/21/1960 | 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 |
|---|---|---|---|---|---|
| 03/25/1985 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1983 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1982 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1980 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1979 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 08/08/1979 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1978 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/1977 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/16/1977 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/28/1978 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 02/09/1979 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1977 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/05/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/29/1977 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |