Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015417
Company: WEST WARD
Company: WEST WARD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPROBAMATE | MEPROBAMATE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| MEPROBAMATE | MEPROBAMATE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/12/1964 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 02/11/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/26/1977 | SUPPL-10 | Labeling |
Label is not available on this site. |