Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203307
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUDOVRA | ESTRADIOL VALERATE;ESTRADIOL VALERATE;DIENOGEST | UNKNOWN | UNKNOWN | 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 |
---|---|---|---|---|---|---|---|
07/27/2018 | ORIG-1 | Tentative Approval |
Label is not available on this site. |