Wednesday, September 21, 2011

Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of September 19, 2011. Table shows the newly added molecule.
DRUG NAMEDOSAGE FORMSTRENGTHRLDDATE OF SUBMISSION
MesalamineDelayed-release Tablets800 mgAsacol HD7/13/2011
Niacin and SimvastatinExtended-release Tablets1000 mg/40 mgSimcor2/4/2011
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