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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
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