Thursday, 23 April 2009

New Paragraph IV filings reported by USFDA till April 21, 2009

Pregabalin (Lyrica) Capsules 25, 50, 75, 100, 150, 200, 225, and 300 mg Para IV filed on Dec 30, 2008


Ropinirole (Requip XL) Extended-release Tablets 4 mg and 8 mg Para IV filed on Oct 31, 2008 and Nov 3, 2008


Venlafaxine Hydrochloride (Venlafaxine hydrochloride) Tablets 37.5, 75, and 150 mg Para IV filed on Feb 12, 2009


Omega-3-acid ethyl esters (Lovaza) Capsules 1 g Para IV filed on Nov 10, 2008



Darifenacin (Enablex) Extended-release Tablets 7.5 and 15 mg Para IV filed on Dec 22, 2008


Doxycycline (Doryx) Delayed-release Tablets 150 mg Para IV filed on Dec19, 2008



Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol 0.15 mg/0.03 mg/0.01 mg Tablets (Seasonique) Para IV filed on Jan 22, 2008

(Source: USFDA)

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