Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202999
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST | ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST | 1MG;2MG;2MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST | ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST | 3MG;2MG;3MG | 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 |
---|---|---|---|---|---|---|---|
03/18/2016 | ORIG-1 | Tentative Approval |
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