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AMOXIL (nda050459)- (250MG,500MG)

AMOXICILLIN GLAXOSMITHKLINE
250MG,500MG
No No
Expired Expired
None None
None No
AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase– negative) strains of the designated microorganisms in the conditions listed below: *Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. *Infections of the genitourinary tract – due to E. coli, P. mirabilis, or E. faecalis. *Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. *Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. *Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females). *H. pylori eradication to reduce the risk of duodenal ulcer recurrence
7 0 6
Total Other Developers None
Drugs with Suitability No
250MG ** ** - 3 -
500MG ** ** - 6 -
NDA Sales Available Total Generic Sales Available
No 3
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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