Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084756
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Discontinued | None | No | No |
| METHOCARBAMOL | METHOCARBAMOL | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/31/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/31/2003 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/2003 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/06/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |