Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009750
Company: DISTA
Company: DISTA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALMID | ETHINAMATE | 500MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/18/1955 | 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 |
|---|---|---|---|---|---|
| 08/09/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/22/1982 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/19/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |