COLUMBUS, Ohio, January 02, 2008 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Balsalazide Disodium Capsules, 750mg by the U.S. Food and Drug Administration. The product is available in bottles of 280 capsules for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Balsalazide Disodium Capsules, 750mg are AB rated to COLAZAL(R) (balsalazide disodium). Annual sales of Balsalazide Disodium Capsules, 750mg are approximately $132 Million(1).
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