Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078767
Company: HIKMA PHARMS
Company: HIKMA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
LEVOFLOXACIN | LEVOFLOXACIN | 750MG | 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 |
---|---|---|---|---|---|---|---|
01/31/2011 | ORIG-1 | Tentative Approval |
Label is not available on this site. |