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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021554
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
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