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ZINACEF (nda050558)- (EQ 1.5GM BASE/VIAL,EQ 7.5GM BASE/VIAL)

CEFUROXIME SODIUM PAI HOLDINGS PHARM
EQ 1.5GM BASE/VIAL,EQ 7.5GM BASE/VIAL
No No
Expired Expired
None None
None No
ZINACEF isindicatedforthetreatmentofpatientswithinfectionscausedbysusceptiblestrains of the designated organisms in the following diseases: 1. Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilusinfluenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcusaureus(penicillinase-and non-penicillinase-producingstrains), Streptococcus pyogenes, and Escherichia coli. 2. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. 3. Skin and Skin-Structure Infections caused by Staphylococcus aureus(penicillinase-and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. 4. Septicemia caused by Staphylococcus aureus (penicillinase-and non-penicillinase-producing strains), Streptococcuspneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. 5. Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcusaureus (penicillinase-and non-penicillinase-producingstrains). 6. Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producingstrains) in both males and females. 7. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase-and nonpenicillinase-producingstrains).
4 0 3
Total Other Developers None
Drugs with Suitability Yes
EQ 1.5GM BASE/VIAL ** ** - - -
EQ 7.5GM 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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