Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209014
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE | CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE | 1MG;10MCG;10MCG | 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 |
---|---|---|---|---|---|---|---|
06/08/2017 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |