Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANTURANE | SULFINPYRAZONE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| ANTURANE | SULFINPYRAZONE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/13/1959 | 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 |
|---|---|---|---|---|---|
| 04/22/1999 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/26/2002 | SUPPL-53 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11556slr053ltr.pdf |
| 09/12/1998 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1993 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1992 | SUPPL-50 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/13/1990 | SUPPL-49 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/08/1987 | SUPPL-48 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/02/1986 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1987 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1985 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1985 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1985 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1983 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1980 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1979 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-32 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/26/1978 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |