Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014547
Company: SANDOZ
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1963 | 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 |
|---|---|---|---|---|---|
| 10/18/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/01/1994 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1987 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/09/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |