Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202975
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
11/20/2015 | ORIG-1 | Approval |
Label is not available on this site. |