Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021554
Company: BAYER PHARMS
Company: BAYER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG; EQ 287.5MG BASE | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG; EQ 574.9MG BASE | TABLET, EXTENDED RELEASE; ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
08/28/2003 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21554_ciproXR_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21554ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021554s000_CirpoXRTOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/28/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21554_ciproXR_lbl.pdf |