Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007883
Company: TEVA WOMENS
Company: TEVA WOMENS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANTABUSE | DISULFIRAM | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ANTABUSE | DISULFIRAM | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/28/1951 | 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 |
|---|---|---|---|---|---|
| 08/29/2000 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 02/21/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 03/27/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/1987 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/28/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 05/20/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/15/1984 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/01/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/26/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/11/1982 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/20/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/20/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 03/20/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/25/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/26/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/21/1980 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/05/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |