Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015500
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
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TOLINASE | TOLAZAMIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TOLINASE | TOLAZAMIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TOLINASE | TOLAZAMIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
07/18/1966 | 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 |
---|---|---|---|---|---|
10/28/1999 | SUPPL-50 | Labeling |
Label is not available on this site. |
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06/25/1987 | SUPPL-48 | Labeling |
Label is not available on this site. |
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06/25/1987 | SUPPL-47 | Labeling |
Label is not available on this site. |
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07/11/1986 | SUPPL-46 | Manufacturing (CMC)-Control |
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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10/03/1984 | SUPPL-43 | Labeling |
Label is not available on this site. |
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05/09/1983 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/24/1978 | SUPPL-40 | Labeling |
Label is not available on this site. |
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12/01/1975 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |