Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071383
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORALONE | TRIAMCINOLONE ACETONIDE | 0.1% | PASTE;DENTAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/06/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |