FDA Approval Activities for this Drug…

Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Ranbaxy ANDA 76-409 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Ranbaxy ANDA 76-409 4/17/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Dr. Reddy's ANDA 76-309 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Dr. Reddy's ANDA 76-309 7/7/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Eon Labs, ANDA 76-302 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Eon Labs, ANDA 76-302 10/28/02 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Roxane, ANDA 76-196 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Roxane, ANDA 76-196 1/14/03 Nefazodone Hydrochloride Tablets, 100, 150, 200 & 250 mg, Mylan ANDA 76-129 9/16/03 Nefazodone Hydrochloride Tablets, 100, 150, 200 & 250 mg, Mylan ANDA 76-129 10/29/02 Nefazodone Hydrochloride Tablets, 150, 200 & 250 mg, Watson, ANDA 76-073 9/16/03 Nefazodone Hydrochloride Tablets, 100, 150, 200 & 250 mg, Watson, ANDA 76-073 10/29/02 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Geneva ANDA 76-072 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Geneva ANDA 76-072 1/30/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Teva ANDA 76-037 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Ivax ANDA 75-763 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Ivax ANDA 75-763 Serzone (nefazodone hydrochloride) Tablets, 50, 100, 150, 200 & 250, Bristol-Myers Squibb Company NDA 20-152/S33 6/20/02 6/24/02 Serzone (nefazodone hydrochloride) Tablets, 50, 100, 150, 200 & 250, Bristol-Myers Squibb Company NDA 20-152/S31 5/5/03 7/9/03 Serzone (nefazodone hydrochloride) Tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg, Bristol-Myers Squibb Company NDA 20-152/S-029 1/8/02 2/8/02 Serzone (nefazodone hydrochloride) Tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg, Bristol-Myers Squibb Company NDA 20-152/S-026 3/21/01 5/1/01 Serzone (nefazodone hydrochloride) Tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg, Bristol-Myers Squibb Company NDA 20-152/S-028 12/4/01 2/12/02 Serzone/Nefazodone HCl Tablets Bristol-Myers Squibb NDA 20152/S011 Serzone (nefazodone hydrochloride) Tablets, Bristol-Myers Squibb | Serzone (nefazodone hydrochloride) Tablets, Bristol-Myers Squibb, Labeling Revision

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