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AUGMENTIN ES-600 (nda050755)- (600MG/5ML;EQ 42.9MG BASE/5ML)

AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS
600MG/5ML;EQ 42.9MG BASE/5ML
No No
Expired Expired
None None
None No
AUGMENTIN ES-600® is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: • antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years or younger 2) daycare attendance
7 0 5
Total Other Developers None
Drugs with Suitability No
600MG/5ML;EQ 42.9MG BASE/5ML ** ** - 4 -
NDA Sales Available Total Generic Sales Available
No 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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