Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016149
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TARACTAN | CHLORPROTHIXENE | 100MG/5ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 06/19/1967 | 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 |
|---|---|---|---|---|---|
| 01/29/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/04/1979 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1976 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/16/1974 | SUPPL-13 | Labeling |
Label is not available on this site. |