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… Zoloft (sertraline hydrochloride) Tablets & Concentrate, Pfizer, NDA 19-839/S045 & 20-990/S011 2/7/03 2/12/03 2/13/03 Zoloft (sertraline hydrochloride) Tablets & Concentrate, Pfizer NDA 19-839/S44 & 20-990/S10 9/16/03 9/25/03 9/25/03 Zoloft (sertraline hydrochloride) Tablets & Concentrate, Pfizer NDA 19-839/S043 & 20-990/S009 9/18/02 9/20/02 Zoloft (sertraline) Tablets & Concentrate, Pfizer NDA 19-839/S039 & 20-990/S007 5/16/02 5/21/02 5/16/02 Zoloft Indication: PMDD (Premenstrual Dysphoric Disorder). Zoloft (sertraline hydrochloride) Tablets & Concentrate, Pfizer NDA 19-839/S036 & 20-990/S004 9/20/02 9/27/02 Zoloft (sertraline hydrochloride) Tablets & Concentrate Pfizer NDA 19-839/S035 & 20-990/S003 8/17/01 11/6/01 11/7/01 11/7/01 Zoloft (sertraline hydrochloride) Tablets & Concentrate Pfizer NDA 20-990/S-001& S002 9/26/02 7/23/03 Zoloft (sertraline hydrochloride) Tablets & Concentrate Pfizer NDA 19-839/S033 & 20-990/S-001 10/12/01 7/31/03 04/25/03 Zoloft (sertraline hydrochloride) Tablets Pfizer NDA 19-839/S026 12/7/99 7/26/01 Zoloft (sertraline hydrochloride) oral concentrate, 20 mg/ml Pfizer NDA 20-990 12/7/99 12/28/99 12/28/99 5/29/01 Zoloft indication: depression, OCD, and panic disorder. Sertraline Hydrochloride Tablets, Genpharm, Sertraline HCI Tabs, Mylan Pharmaceuticals, Zoloft (sertraline hydrochloride) oral concentrate, Pfizer Pharmaceuticals, Labeling Revision & Efficacy Supplement with Clinical Data to Support Zoloft (sertraline hydrochloride) tablets, Pfizer Pharmaceuticals, Labeling Revision & Efficacy Supplement with Clinical Data to Support | Sertraline Hydrochloride Tablets, Ivax Pharmaceuticals, Tentative Approval | Zoloft (sertraline hydrochloride) tablets, Pfizer Pharma, Labeling Revision | Zoloft (sertraline hydrochloride)oral concentrate, Pfizer Pharma, Labeling Revision | Sertraline Hydrochloride Tablets, Roxane Labs, Tentative Approval | Sertraline Hydrochloride Tablets, Andrx Pharma, Tentative Approval | Zoloft (sertraline hydrochloride) tablets, Pfizer Pharma, Labeling Revision | Zoloft (sertraline hydrochloride) oral concentrate, Pfizer Pharma, Labeling Revision | Sertraline Hydrochloride, Tablets, Aurobindo Pharma Limited, Inc., Tentative Approval | Sertraline Hydrochloride Tablets, Purepac Pharma, Tentative Approval | Sertraline Hydrochloride Tablets, Dr. Reddy’s Labs, Tentative Approval | Sertraline Hydrochloride Tablets, Pliva, Tentative Approval | Sertraline Hydrochloride Oral Concentrate, Roxane Labs, Tentative Approval | Sertraline Hydrochloride Tablets, InvaGen Pharma, Tentative Approval | Sertraline Hydrochloride Tablets, Zydus Pharma, Tentative Approval | Zoloft (sertraline hydrochloride) tablets, Pfizer Inc., Labeling Revision | Zoloft (sertraline hydrochloride) oral concentrate, Pfizer Inc., Labeling Revision | Sertraline Hydrochloride Tablets, InvaGen Pharma, Tentative Approval | Sertraline Hydrochloride Tablets, Mutual Pharma, Tentative Approval | Sertraline Hydrochloride Tablets, Teva Pharma, Approval | Sertraline Hydrochloride, Sandoz, Tentative Approval | Zoloft (sertraline hydrochloride) tablets, Pfizer Pharma, Labeling Revision | Zoloft (sertraline hydrochloride) oral concentrate, Pfizer Pharma, Labeling Revision | Sertraline Hydrochloride Tablets, Apotex Inc., Tentative Approval | Sertraline Hydrochloride Oral Concentrate, Ranbaxy, Tentative Approval | Sertraline Hydrochloride Tablets, Lupin Ltd., Tentative Approval | Sertraline Hydrochloride Tablets, Watson Labs, Tentative Approval | Sertraline Hydrochloride Tablets, Sun Pharma, Tentative Approval | Sertraline Hydrochloride Oral Concentrate, Ranbaxy Inc., Approval | Sertraline Hydrochloride Tablets, Sandoz Inc., Approval | Sertraline Hydrochloride Tablets, Barr Labs, Approval | Sertraline Hydrochloride Tablets, Cobalt Pharma, Approval | Sertraline Hydrochloride Tablets, Sun Pharma, Approval | Sertraline Hydrochloride Tablets, Zydus Pharma, Approval | Sertraline Hydrochloride Tablets, Mutual Pharma, Approval | Sertraline Hydrochloride Tablets, Myland Pharma, Approval | Sertraline Hydrochloride Tablets, Aurobindo Pharma, Approval | Sertraline Hydrochloride Tablets, Apotex Inc., Approval | Sertraline Hydrochloride Tablets, Actavis Elizabeth, Approval | Sertraline Hydrochloride Tablets, InvaGen Pharma, Approval | Sertraline Hydrochloride Tablets, Ranbaxy Inc., Approval | Sertraline Hydrochloride Tablets, Lupin Ltd., Approval | Sertraline Hydrochloride Tablets, Watson Labs, Approval | Sertraline Hydrochloride Tablets, Roxane Labs, Approval | Sertraline Hydrochloride Tablets, Genpharm Inc., Approval | Sertraline Hydrochloride Tablets, Dr. Reddy’s Labs, Approval | Zoloft (sertraline HCl) Tablets, Pfizer Pharma, Labeling Revision | Zoloft (sertraline HCl) Oral Concentrate, Pfizer Pharma, Labeling Revision | Zoloft (sertraline hydrochloride) Tablets, Pfizer Pharma, Labeling Revision | Zoloft (sertraline hydrochloride) Oral Concentrate, Pfizer Pharma, Labeling Revision | Sertraline Hydrochloride Tablets, Wockhardt, Approval | Sertraline Hydrochloride Tablets, Mylan Pharma, Approval | Zoloft (sertraline hydrochloride) Tablets, Pfizer Pharma, Labeling Revision | Zoloft (sertraline hydrochloride) Oral Concentrate, Pfizer Pharma, Labeling Revision | Sertraline Hydrochloride Oral Concentrate, Aurobindo Pharma 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