Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083919
Company: MEDPOINTE PHARM HLC
Company: MEDPOINTE PHARM HLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MILTOWN | MEPROBAMATE | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/28/1974 | 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 |
|---|---|---|---|---|---|
| 12/30/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/03/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |