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OMNICEF (nda050739)- (300MG)

CEFDINIR ABBVIE
300MG
No No
2011-Dec-04 Expired
None None
None No
OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1) Adults and Adolescents:- *Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including βlactamase producing strains). * Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including βlactamase producing strains). * Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). * Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. * Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. 2) Pediatric Patients:- * Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). * Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. * Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.
6 0 5
Total Other Developers None
Drugs with Suitability No
300MG ** ** - - 4
NDA Sales Available Total Generic Sales Available
No 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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