The list of Paragraph IV certification is updated by FDA as of January 17, 2011 and it includes 4 new listing as below..
1) Dexlansoprazole Capsules 60 mg (RLD-Dexilant) (Date-25 Aug 2010)
2) Dutasteride and Tamsulosin Hydrochloride Capsules 0.5 mg/0.4 mg (RLD-Jalyn) (Date-26 Oct 2010)
3) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral solution 17.5 g/3.13 g/1.6 g per bottle (RLD-Suprep Bowel Prep Kit) (Date-08 Nov 2010)
4) Voriconazole Oral suspension (RLD-Vfend) (Date- 08 Oct 2010)
In my previous post i have mentioned about the suit by pfizer for Vfend (Voriconazole) against Novartis on filing ANDA with para IV certification for Vfend oral suspension.
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