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OTOVEL (nda208251)- (EQ 0.3% BASE;0.025%)

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE LABORATORIOS SALVAT
EQ 0.3% BASE;0.025%
No Yes
2030-Mar-24 Expired
None None
None No
OTOVEL is a combination of ciprofloxacin, a fluoroquinolone antibacterial, and fluocinolone acetonide, a corticosteroid, indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 0.3% BASE;0.025% ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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