1) Cyclobenzaprine (Amrix) Extended-release Capsule 15 mg and 30 mg (Para IV filing date: Aug 11, 2008)
2) Sevelamer (Renagel) Tablets 400 mg and 800 mg (Para IV filing date: May 22, 2008)
3) Sumatriptan and Naproxen (Treximet) Tablets 85 mg/500 mg (Para IV filing date: July 23,2008)
4) Paricalcitol (Zemplar) Capsules 4 mcg (Para IV filing date: Aug 25, 2008)
5) Oxybutynin (Oxytrol) Transdermal System Extended-release 3.9 mg/24 hrs (Para IV filing date: Aug 19, 2008)
6) Clozapine (Fazaclo) Orally Disintegrating Tablets 12.5 mg (Para IV filing date: June 5, 2008)
7) Amlodipine and Olmesartan (Azor) Tablets 10 mg/20 mg and 5 mg/40 mg (Para IV filing date: March 31, 2008)
Monday, 3 November 2008
New Paragraph IV filings reported by USFDA in October 2008
Posted by ADKS at 11:31 am
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