Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207585
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RHUZDAH | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
10/11/2022 | ORIG-1 | Approval | STANDARD |
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