Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010670
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORINASE | TOLBUTAMIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| ORINASE | TOLBUTAMIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 05/31/1957 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/1987 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 12/19/1986 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 03/24/1986 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 10/18/1984 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 12/08/1977 | SUPPL-34 | Labeling |
Label is not available on this site. |