Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017914
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIDESILON | ACETIC ACID, GLACIAL; DESONIDE | 2%;0.05% | SOLUTION/DROPS;OTIC | 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 |
|---|---|---|---|---|---|---|---|
| 02/21/1978 | 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 |
|---|---|---|---|---|---|
| 03/04/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/25/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/29/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |