Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. ANDA 76593, held by Aiping Pharm Inc. Ciprofloxacin, Ciprofloxacin Hydrochloride.
As of Nov 15, 2026, ANDA 76593 (Ciprofloxacin, Ciprofloxacin Hydrochloride), held by Aiping Pharm Inc, was first approved by FDA on Mar 16, 2004, 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 16, 2004 | Original application | Approved |
| Ciprofloxacin100MG · tablet; oral | Ciprofloxacin | None (tentative approval) |
| Ciprofloxacin HydrochlorideEQ 250MG BASE · tablet;oral | Ciprofloxacin Hydrochloride | Rx |
| Ciprofloxacin HydrochlorideEQ 500MG BASE · tablet;oral | Ciprofloxacin Hydrochloride | Rx |
| Ciprofloxacin HydrochlorideEQ 750MG BASE · tablet;oral | Ciprofloxacin Hydrochloride | Rx |
| Oct 31, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 31, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 16, 2004 | 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
