FDA Approval Activities for this Drug…

Ticlid (Ticlopidine Hydrochloride) Tablets, Syntex NDA 19-979/S019 6/14/00 6/4/01 Ticlid (Ticlopidine Hydrochloride) Tablets, Syntex NDA 19-979/SE1-018 4/18/01 4/8/03 5/9/03 12/18/01 Ticlid Indications: adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation. Ticlopidine Hydrochloride Tablets, 250 mg, Caraco Pharmaceutical , Ltd. ANDA 75-526 9/26/02 Ticlopidine Hydrochloride Tablets, 250 mg. Eon Labs ANDA 75-326 8/20/99 8/26/99 12/20/01 Ticlopidine Hydrochloride Tablets, 250 mg. Invamed, ANDA 75-318 8/20/99 8/26/99 4/22/03 Ticlopidine Hydrochloride Tablets,250mg Mylan ANDA 75-316 11/2/99 12/30/99 Ticlopidine Hydrochloride Tablets,250 mg, Danbury Pharmacal, ANDA 75-309 4/26/00 4/28/00 Ticlopidine Hydrochloride Tablets,250mg Purepac Pharmaceutical ANDA 75-253 8/20/99 8/26/99 4/22/03 Ticlopidine Hydrochloride Tablets,250mg Genpharm, ANDA 75-161 9/13/99 9/14/99 8/6/03 Ticlopidine Hydrochloride Tablets, 250 mg, Teva USA ANDA 75-149 8/20/99 8/26/99 Ticlopidine Hydrochloride Tablets, 250 mg. Apotex Corp ANDA 75-089 7/1/99 7/2/99 Ticlopidine Hydrochloride Tablets, 250 mg. (tentatively approved) Novopharm N.C. ANDA 74-994

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