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FDA Approval Activities for this Drug… Actigall (ursodiol) Capsules, Novartis NDA 19-594/S-021 Urso® (ursodiol) Tablets., Axcan Scandipharm, NDA 20-675/S-006 & 20-675/S-007 3/8/01 4/25/01 Ursodiol Capsules USP, 300 mg, Copley Pharmaceutical, ANDA 75-592 5/25/00 6/6/00 12/5/01 Ursodiol Capsules USP,300 mg, Amide Pharmaceutical, ANDA 75-517 URSODIOL Capsule; 300MG URSODIOL Amide 075592 URSODIOL Capsule; 300MG URSODIOL Copley 019594 URSODIOL Capsule; 300MG ACTIGALL Watson 020675 URSODIOL Tablet; 250MG URSO AXCAN SCANDIPHARM URSO 250 (ursodiol) Tablets, Axcan Scandipharm, New Dosage Regimen | URSO 250 and Ursodiol 500 mg Tablets, Axcan Scandipharm, Labeling Revision | Ursodiol Capsules, CorePharma, Approval | Urso Forte (ursodiol, USP) Tablets, Axcan Scandipharm, Package Change ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com