Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200835
Company: WATSON LABS INC
Company: WATSON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPROPION HYDROBROMIDE | BUPROPION HYDROBROMIDE | 174MG | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
BUPROPION HYDROBROMIDE | BUPROPION HYDROBROMIDE | 522MG | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
08/13/2013 | ORIG-1 | Tentative Approval | Not Applicable |
Label is not available on this site. |