Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008319
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTAZOLIDIN | PHENYLBUTAZONE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| BUTAZOLIDIN | PHENYLBUTAZONE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 06/25/1997 | SUPPL-90 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-89 | Labeling |
Label is not available on this site. |
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| 01/03/1989 | SUPPL-88 | Labeling |
Label is not available on this site. |
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| 09/13/1988 | SUPPL-87 | Labeling |
Label is not available on this site. |
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| 09/30/1985 | SUPPL-85 | Labeling |
Label is not available on this site. |
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| 03/04/1985 | SUPPL-83 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-81 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-79 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-77 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-72 | Labeling |
Label is not available on this site. |
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| 08/06/1979 | SUPPL-64 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 08/22/1977 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 05/16/1977 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 05/18/1977 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 05/16/1977 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-46 | Labeling |
Label is not available on this site. |