Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016249
Company: SOLVAY
Company: SOLVAY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRANMEP | MEPROBAMATE | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/1967 | 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 |
|---|---|---|---|---|---|
| 01/29/1975 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 01/14/1975 | SUPPL-55 | Labeling |
Label is not available on this site. |
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| 01/14/1975 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1974 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 09/17/1974 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/27/1974 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 07/19/1974 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1974 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1974 | SUPPL-43 | Unspecified |
Label is not available on this site. |
||
| 09/04/1974 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-25 | Unspecified |
Label is not available on this site. |