Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076405
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRI-LEGEST 21 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | TABLET;ORAL-21 | 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 |
---|---|---|---|---|---|---|---|
10/26/2007 | ORIG-1 | Approval |
Label is not available on this site. |