FDA Approval Activities for this Drug…

Etodolac Capsules, 200 mg & 300 mg. Torpharm ANDA 75-419 7/28/00 10/30/00 Etodolac Capsules, 200 mg & 300 mg. Novopharm NC, ANDA 75-126 9/16/99 9/24/99 Etodolac Capsules, 200 mg & 300 mg. Taro USA, ANDA 75-078 4/30/98 3/19/99 Etodolac Capsules, 200 mg and 300 mg, Genpharm ANDA 75-071 9/30 9/30 Etodolac Capsules, 300 mg. Aesgen ANDA 74-929 1/30/98 3/19/99 Etodolac Extended-Release Tablets, 400, 500 & 600 mg, Taro Pharmaceutical Industries ANDA 76-174 3/13/03 Etodolac Extended-Release Tablets, 400, 500 & 600 mg, Eon Labs, ANDA 75-943 7/26/02 Etodolac Extended-Release Tablets, 500 mg, Andrx ANDA 75-829 11/30/01 4/15/03 Etodolac Extended-Release Tablets, 400 mg, Whitney ANDA 75-696 7/31/00 11/7/00 Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mg, Teva ANDA 75-665/S-1,2,3 2/5/01 3/5/01 Etodolac Extended-Release Tablets, 400 mg, 500 mg and 600 mg, 7/31/00 Teva ANDA 75-665 7/31/00 11/7/00 Etodolac Tablets, 400 mg and 500 mg, Apotex Corp. ANDA 76-004 12/3/02 Etodolac Tablets, 400 mg and 500 mg Ranbaxy ANDA 75-226 11/24/98 11/24/98 Etodolac Tablets, 400 mg. Taro U.S.A., ANDA 75-074 3/11/98 3/19/99 Etodolac Tablets, 400 mg Chelsea ANDA 75-069 4/16/98 5/6/98 3/19/99 Etodolac Tablets, 400 mg and 500 mg, Genpharm ANDA 75-012 9/30/98 9/30/98 Etodolac Tablets, 400 mg. Teva ANDA 75-009/S2, S3, S4, S5 & S6 12/28/99 9/24/02 Etodolac Tablets, 400 mg. Mylan ANDA 75-104 2/6/98 3/22/99 Etodolac Tablets, 400 mg and 500 mg Novopharm Limited ANDA 74-847 Lodine XL (etodolac) Tablets, 400 mg, 500 mg, and 600 mg, Wyeth-Ayerst Research NDA 20-584/S-005 8/11/00 11/9/01 Lodine XL (etodolac extended-release tablets) Tablets, 400 mg, 500 mg, and 600 mg, Wyeth-Ayerst Research NDA 20-584/S-003, SE2 5/27/99 7/18/01 Lodine XL Indications: For the management of the signs and symptoms of osteoarthritis and rheumatoid arthritis. Lodine XL (etodolac extended-release tablets) Tablets, 400 mg, 500 mg, and 600 mg, Wyeth-Ayerst Research NDA 20-584/S-001 ETODOLAC Capsule; 300MG ETODOLAC AAIPHARMA 074842 ETODOLAC Capsule; 200MG ETODOLAC ENDO 074842 ETODOLAC Capsule; 300MG ETODOLAC ENDO 074840 ETODOLAC Capsule; 200MG ETODOLAC Geneva 074840 ETODOLAC Capsule; 300MG ETODOLAC Geneva 074942 ETODOLAC Capsule; 200MG ETODOLAC Geneva TECH 074942 ETODOLAC Capsule; 300MG ETODOLAC Geneva TECH 075071 ETODOLAC Capsule; 200MG ETODOLAC Genpharm 075071 ETODOLAC Capsule; 300MG ETODOLAC Genpharm 074899 ETODOLAC Capsule; 200MG ETODOLAC Ivax 074899 ETODOLAC Capsule; 300MG ETODOLAC Ivax 074932 ETODOLAC Capsule; 200MG ETODOLAC Mylan 074932 ETODOLAC Capsule; 300MG ETODOLAC Mylan 075078 ETODOLAC Capsule; 200MG ETODOLAC Taro 075078 ETODOLAC Capsule; 300MG ETODOLAC Taro 075126 ETODOLAC Capsule; 200MG ETODOLAC Teva 075126 ETODOLAC Capsule; 300MG ETODOLAC Teva 075419 ETODOLAC Capsule; 200MG ETODOLAC Torpharm 075419 ETODOLAC Capsule; 300MG ETODOLAC Torpharm 074844 ETODOLAC Capsule; 200MG ETODOLAC Watson 074844 ETODOLAC Capsule; 300MG ETODOLAC Watson 018922 ETODOLAC Capsule; 200MG LODINE Wyeth INC 018922 ETODOLAC Capsule; 300MG LODINE Wyeth INC 075829 ETODOLAC Tablet, Extended Release; 400MG ETODOLAC Andrx 075829 ETODOLAC Tablet, Extended Release; 500MG ETODOLAC Andrx 075943 ETODOLAC Tablet, Extended Release; 400MG ETODOLAC Eon 075943 ETODOLAC Tablet, Extended Release; 500MG ETODOLAC Eon 075943 ETODOLAC Tablet, Extended Release; 600MG ETODOLAC Eon 075696 ETODOLAC Tablet, Extended Release; 400MG ETODOLAC POINT HOLDINGS 076174 ETODOLAC Tablet, Extended Release; 400MG ETODOLAC Taro 076174 ETODOLAC Tablet, Extended Release; 500MG ETODOLAC Taro 076174 ETODOLAC Tablet, Extended Release; 600MG ETODOLAC Taro 075665 ETODOLAC Tablet, Extended Release; 400MG ETODOLAC Teva 075665 ETODOLAC Tablet, Extended Release; 500MG ETODOLAC Teva 075665 ETODOLAC Tablet, Extended Release; 600MG ETODOLAC Teva 020584 ETODOLAC Tablet, Extended Release; 400MG LODINE XL Wyeth INC 020584 ETODOLAC Tablet, Extended Release; 500MG LODINE XL Wyeth INC 020584 ETODOLAC Tablet, Extended Release; 600MG LODINE XL Wyeth INC 074927 ETODOLAC Tablet; 400MG ETODOLAC AAIPHARMA 076004 ETODOLAC Tablet; 400MG ETODOLAC Apotex 076004 ETODOLAC Tablet; 500MG ETODOLAC Apotex 074841 ETODOLAC Tablet; 400MG ETODOLAC ENDO 074903 ETODOLAC Tablet; 400MG ETODOLAC Eon 074903 ETODOLAC Tablet; 500MG ETODOLAC Eon 074839 ETODOLAC Tablet; 400MG ETODOLAC Geneva 074846 ETODOLAC Tablet; 400MG ETODOLAC Geneva TECH 075012 ETODOLAC Tablet; 400MG ETODOLAC Genpharm 075012 ETODOLAC Tablet; 500MG ETODOLAC Genpharm 074883 ETODOLAC Tablet; 400MG ETODOLAC Ivax 074883 ETODOLAC Tablet; 500MG ETODOLAC Ivax 075104 ETODOLAC Tablet; 400MG ETODOLAC Mylan 075104 ETODOLAC Tablet; 500MG ETODOLAC Mylan 074819 ETODOLAC Tablet; 400MG ETODOLAC Purepac 075226 ETODOLAC Tablet; 400MG ETODOLAC Ranbaxy 075226 ETODOLAC Tablet; 500MG ETODOLAC Ranbaxy 075074 ETODOLAC Tablet; 400MG ETODOLAC Taro INDS 075074 ETODOLAC Tablet; 500MG ETODOLAC Taro INDS 074847 ETODOLAC Tablet; 400MG ETODOLAC Teva 075009 ETODOLAC Tablet; 400MG ETODOLAC Teva 075009 ETODOLAC Tablet; 500MG ETODOLAC Teva 074847 ETODOLAC Tablet; 500MG ETODOLAC Teva 075069 ETODOLAC Tablet; 400MG ETODOLAC Watson 074892 ETODOLAC Tablet; 400MG ETODOLAC Watson 074892 ETODOLAC Tablet; 500MG ETODOLAC Watson 018922 ETODOLAC Tablet; 400MG LODINE Wyeth INC 018922 ETODOLAC Tablet; 500MG LODINE Wyeth INC

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