Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083215
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE | BROMPHENIRAMINE MALEATE | 4MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/1975 | 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 |
|---|---|---|---|---|---|
| 09/30/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1982 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1982 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |