Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090815
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRBESARTAN; HYDROCHLOROTHIAZIDE | IRBESARTAN; HYDROCHLOROTHIAZIDE | 150MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| IRBESARTAN; HYDROCHLOROTHIAZIDE | IRBESARTAN; HYDROCHLOROTHIAZIDE | 300MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| IRBESARTAN; HYDROCHLOROTHIAZIDE | IRBESARTAN; HYDROCHLOROTHIAZIDE | 300MG; 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 |
|---|---|---|---|---|---|---|---|
| 02/16/2011 | ORIG-1 | Tentative Approval |
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