Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078577
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
LEVOFLOXACIN | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/12/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078577Orig1s000ltr.pdf |