Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010599
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAL | HEXOCYCLIUM METHYLSULFATE | 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 |
|---|---|---|---|---|---|---|---|
| 02/13/1957 | 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 |
|---|---|---|---|---|---|
| 04/14/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/07/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/07/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/07/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |