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FLOXIN OTIC (nda020799)- (0.3%)

OFLOXACIN DAIICHI
0.3%
Yes No
2012-Mar-27 Expired
None None
None No
FLOXIN® Otic (ofloxacin otic solution) 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa Staphylococcus aureus, and Streptococcus pneumoniae.
8 0 7
Total Other Developers None
Drugs with Suitability No
0.3% ** ** - - 5
NDA Sales Available Total Generic Sales Available
No 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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