Friday, April 22, 2011

Paragraph IV list update

USFDA has updated Paragraph IV certification list as of April 18, 2011. Table shows the newly added molecule.



DRUG NAME
DOSAGE FORM
STRENGTH
RLD
DATE OF SUBMISSION
Glycopyrrolate
Tablets
1 mg
Robinul
8/14/2009
Glycopyrrolate
Tablets
2 mg
Robinul Forte
10/12/2010
Hydromorphone hydrochloride
Oral Solution
5 mg/5mL
Dilaudid
2/25/2011
Azithromycin
Ophthalmic Solution
1%
Azasite
3/3/2011

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