FDA Approval Activities for this Drug…

Nabumetone Tablets, 500 mg, Second () Copley Pharmaceutical, ANDA 75-179 6/6/00 6/9/00 12/31/01 Nabumetone Tablets, 500 mg & 750 mg, Teva USA ANDA 75-189 S-01, S-02 9/24/01 4/9/03 Nabumetone Tablets, 500 mg & 750 mg, Teva USA ANDA 75-189 5/26/00 6/6/00 12/28/01 Nabumetone Tablets, 500 mg and 750 mg, (Tentatively approved 12/24/98) Teva USA ANDA 75-189 12/24/98 12/24/98 Nabumetone Tablets, 500 mg and 750 mg, Eon Labs Manufacturing ANDA 75-280 2/25/02 4/10/03 Nabumetone Tablets, 500 mg and 750 mg, August 6 Eon Labs Manufacturing ANDA 75-280 8/6/98 8/7/98 Nabumetone Tablets, 500 mg and 750 mg, Invamed ANDA 75-590 2/25/02 Nabumetone Tablets, 500 mg and 750 mg, 3/21/01 Invamed ANDA 75-590 3/21/01 3/30/01 Nabumetone Tablets, 500 mg and 750 mg, Ivax ANDA 76-009 NABUMETONE Tablet; 750MG NABUMETONE Copley 075280 NABUMETONE Tablet; 500MG NABUMETONE Eon 075280 NABUMETONE Tablet; 750MG NABUMETONE Eon 019583 NABUMETONE Tablet; 500MG RELAFEN GLAXOSMITHKLINE 019583 NABUMETONE Tablet; 750MG RELAFEN GLAXOSMITHKLINE 075590 NABUMETONE Tablet; 500MG NABUMETONE INVAMED 075590 NABUMETONE Tablet; 750MG NABUMETONE INVAMED 076009 NABUMETONE Tablet; 500MG NABUMETONE Ivax 076009 NABUMETONE Tablet; 750MG NABUMETONE Ivax 075189 NABUMETONE Tablet; 500MG NABUMETONE Teva 075189 NABUMETONE Tablet; 750MG NABUMETONE Teva

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