Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012487
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TARACTAN | CHLORPROTHIXENE | 12.5MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/23/1962 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-25 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 09/27/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 01/29/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/08/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/16/1974 | SUPPL-12 | Labeling |
Label is not available on this site. |