Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012486
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TARACTAN | CHLORPROTHIXENE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| TARACTAN | CHLORPROTHIXENE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| TARACTAN | CHLORPROTHIXENE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| TARACTAN | CHLORPROTHIXENE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/1962 | 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 |
|---|---|---|---|---|---|
| 01/09/1997 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 01/29/1981 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/16/1974 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |