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CIPRO (nda019537)- (EQ 100MG BASE,EQ 250MG BASE,EQ 500MG BASE,EQ 750MG BASE)

CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE
EQ 100MG BASE,EQ 250MG BASE,EQ 500MG BASE,EQ 750MG BASE
Yes No
2011-Aug-15 Expired
None None
None No
CIPRO 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 Cystitis, Complicated UTI and Pyelonephritis in Pediatric Patients • Acute Sinusitis.
12 2 8
Total Other Developers 8
Drugs with Suitability No
EQ 100MG BASE ** ** - - -
EQ 250MG BASE ** ** - 8 -
EQ 500MG BASE ** ** - - 8
EQ 750MG BASE ** ** - 6 -
NDA Sales Available Total Generic Sales Available
No 7
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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