Wednesday, August 24, 2011

Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of August 22, 2011. Table shows the newly added molecule.


DRUG NAME
DOSAGE FORM
STRENGTH
RLD
DATE OF SUBMISSION
Clozapine
Orally Disintegrating
Tablets
150 mg
Fazaclo
4/8/2011
Clozapine
Orally Disintegrating
Tablets
200 mg
Fazaclo
4/18/2011

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