Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | RELAFEN (nabumetone) Tablet, GlaxoSmithKline, Labeling Revision | Relafen (nabumetone) Tablets, GlaxoSmithKline, Labeling Revision | Nabumetone Tablets, InvaGen Pharma, Approval | Nabumetone Tablets, Dr. Reddy's Laboratories, Ltd., Approval ^ 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