Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084153
Company: ACELLA
Company: ACELLA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPROBAMATE | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1974 | 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 |
|---|---|---|---|---|---|
| 06/26/1989 | SUPPL-44 | Bioequivalence |
Label is not available on this site. |
||
| 08/04/1983 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1983 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |