Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214729
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETYQA | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Discontinued | None | No | No |
ETYQA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/30/2023 | ORIG-1 | Approval | STANDARD |
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