Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009489
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PATHILON | TRIDIHEXETHYL CHLORIDE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/1954 | 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 |
|---|---|---|---|---|---|
| 11/07/1991 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/09/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/27/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/28/1988 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/16/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |