Thursday, April 23, 2009

New Paragraph IV filings reported by USFDA till April 23, 2009

Brimonidine Tartrate and Timolol Maleate 0.2%/0.5% Ophthalmic Solution (Combigan) Para IV filed on Nov 21, 2008

Capecitabine 150 mg and 500 mg Tablets (Xeloda). Para IV filed on Nov 10, 2008

Diclofenac Sodium and Misoprostol 75 mg/0.2 mg Delayed-release Tablets (Arthrotec) Para IV filed on Nov 28, 2008

Guaifenesin and Dextromethorphan 600 mg/30 mg and 1200 mg/60 mg Extended-release Tablets (Mucinex DM) Para IV filed on Dec 17, 2008

Lovastatin and Niacin 20 mg/750 mg Extended-release Tablets (Advicor) Para IV filed on Dec 17, 2008

Sevelamer Carbonate 800 mg tablets (Renvela) Renvela Para IV filed on Dec 4, 2008


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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