Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076538
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60/120MG | TABLET, EXTENDED RELEASE; 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 |
---|---|---|---|---|---|---|---|
04/30/2004 | ORIG-1 | Tentative Approval |
Label is not available on this site. |