Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. ANDA 200563, held by Chartwell. Ciprofloxacin.
As of Nov 15, 2026, ANDA 200563 (Ciprofloxacin), held by Chartwell, was first approved by FDA on Mar 5, 2014, with 2 approved supplements and 0 published complete response letters.
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections Bone and Joint Infections Complicated Intra-Abdominal Infections Infectious Diarrhea Typhoid Fever (Enteric Fever) Uncomplicated Cervical and Urethral Gonorrhea Inhalational Anthrax post-exposure in adult and pediatric patients Plague in adult and pediatric patients Chronic Bacterial Prostatitis Lower Respiratory Tract Infections Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections Urinary Tract Infections (UTI) Acute Uncomplicated Cys…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2014 | Original application | Approved |
| Ciprofloxacin250MG/5ML · for suspension;oral | Ciprofloxacin | Rx |
| Ciprofloxacin500MG/5ML · for suspension;oral | Ciprofloxacin | Rx |
| Oct 14, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 6, 2015 | Supplement 1Manufacturing | Approved | None posted |
| Mar 5, 2014 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
