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… 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 ^ 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