Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091084
Company: WATSON LABS FLORIDA
Company: WATSON LABS FLORIDA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TELMISARTAN; HYDROCHLOROTHIAZIDE | TELMISARTAN; HYDROCHLOROTHIAZIDE | 40MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| TELMISARTAN; HYDROCHLOROTHIAZIDE | TELMISARTAN; HYDROCHLOROTHIAZIDE | 80MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| TELMISARTAN; HYDROCHLOROTHIAZIDE | TELMISARTAN; HYDROCHLOROTHIAZIDE | 80MG; 25MG | TABLET; 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 |
|---|---|---|---|---|---|---|---|
| 09/15/2011 | ORIG-1 | Tentative Approval |
Label is not available on this site. |