Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205550
Company: JUBILANT GENERICS
Company: JUBILANT GENERICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
10/12/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |