Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076484
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/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 |
---|---|---|---|---|---|---|---|
08/28/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076484s000ltr.pdf |