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MEFOXIN (nda050517)- (EQ 1GM BASE/VIAL,EQ 2GM BASE/VIAL,EQ 10GM BASE/VIAL)

CEFOXITIN SODIUM NORVIUM BIOSCIENCE
EQ 1GM BASE/VIAL,EQ 2GM BASE/VIAL,EQ 10GM BASE/VIAL
No No
Expired Expired
None None
None No
MEFOXIN is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Staphylococcus aureus (including penicillinaseproducing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species. (2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri). (3) Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species. (4) Gynecological infections, including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Streptococcus agalactiae. (5) Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis. (6) Bone and joint infections caused by Staphylococcus aureus (including Penicillinaseproducing strains). 7) Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, and Peptostreptococcus species.
3 0 2
Total Other Developers None
Drugs with Suitability Yes
EQ 1GM BASE/VIAL ** ** - - -
EQ 2GM BASE/VIAL ** ** - - -
EQ 10GM BASE/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
No 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** ***** ************ ***** ************ (********), *.* *********** ******* *** ** **, */**/**, ******** ******, ****-***, ******** (***) ***

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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