Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014882
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| 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 |
|---|---|---|---|---|---|---|---|
| 08/09/1963 | 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 |
|---|---|---|---|---|---|
| 08/22/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/22/1981 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1978 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/08/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |