Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010653
Company: 3M
Company: 3M
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DISIPAL | ORPHENADRINE HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/1957 | 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 |
|---|---|---|---|---|---|
| 04/28/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1977 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/22/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |