|
|
|
 |
FDA Approval Activities for this Drug…
Asimia (paroxetine mesylate) Tablets, 10 mg, 20 mg, 30 mg, and 40 mg, Synthon Ltd. NDA 21-299 Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Alphapharm ANDA 75-716 9/29/03 Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Apotex /U.S Agent for Torpharm ANDA 75-356 7/30/03 7/31/03 Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Torpharm ANDA 75-356 5/24/01 6/5/01 Paroxetine Mesylate Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Synthon NDA 21-299/S1 8/21/03 8/28/03 Paroxetine Mesylate Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Synthon NDA 21-299 Paxil CR (paroxetine HCl) Tablets, GlaxoSmithKline NDA 20-936/S-012 8/28/03 10/17/03 10/17/03 | Paxil CR (paroxetine HCl) Tablets, GlaxoSmithKline NDA 20-936/S-011 8/28/03 09/09/03 09/09/03 | Paxil CR (paroxetine HCl) Tablets, GlaxoSmithKline NDA 20-982 & 20-936/S-008 2/12/02 2/21/02 2/21/02 6/25/02 Paxil CR (paroxetine HCl) Tablets, 12.5 and 25 mg, SmithKline Beecham NDA 20-936 2/16/99 2/17/99 3/4/99 7/26/01 | Paxil Indication: Treatment of Depression | Paxil Capsules, 10 mg, 20 mg, 30, and 40 mg, SmithKline Beecham NDA 20-885 10/9/98 10/13/98 12/14/98 | Paxil Indication: Depression/OCD/Panic Disorder | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline NDA 20-031/S-035 10/2/02 10/2/02 | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline NDA 20-031/S-023 5/11/99 4/24/03 | Paxil (paroxetine) Tablets, GlaxoSmithKline NDA 20-031/S-029 12/14/01 2/12/02 2/12/02 | Paxil (paroxetine hydrochloride) Tablets SmithKline Beecham NDA 20-031/S-023 5/17/99 5/18/99 | Paxil (paroxetine HCl) Tablets, GlaxoSmithKline NDA 20-031/S-026 PAROXETINE HYDROCHLORIDE Suspension; 10MG BASE/5ML PAXIL GLAXOSMITHKLINE | 020936 PAROXETINE HYDROCHLORIDE Tablet, Extended Release; 12.5MG BASE PAXIL CR GLAXOSMITHKLINE | 020936 PAROXETINE HYDROCHLORIDE Tablet, Extended Release; 25MG BASE PAXIL CR GLAXOSMITHKLINE | 020936 PAROXETINE HYDROCHLORIDE Tablet, Extended Release; 37.5MG BASE PAXIL CR GLAXOSMITHKLINE | 020031 PAROXETINE HYDROCHLORIDE Tablet; 10MG BASE PAXIL GLAXOSMITHKLINE | 020031 PAROXETINE HYDROCHLORIDE Tablet; 20MG BASE PAXIL GLAXOSMITHKLINE | 020031 PAROXETINE HYDROCHLORIDE Tablet; 30MG BASE PAXIL GLAXOSMITHKLINE | 020031 PAROXETINE HYDROCHLORIDE Tablet; 40MG BASE PAXIL GLAXOSMITHKLINE | 075356 PAROXETINE HYDROCHLORIDE Tablet; 10MG BASE PAROXETINE HCL Torpharm | 075356 PAROXETINE HYDROCHLORIDE Tablet; 20MG BASE PAROXETINE HCL Torpharm | 075356 PAROXETINE HYDROCHLORIDE Tablet; 30MG BASE PAROXETINE HCL Torpharm | 075356 PAROXETINE HYDROCHLORIDE Tablet; 40MG BASE PAROXETINE HCL Torpharm | 021299 PAROXETINE MESYLATE Tablet; 10MG BASE PAROXETINE MESYLATE SYNTHON 021299 PAROXETINE MESYLATE Tablet; 20MG BASE PAROXETINE MESYLATE SYNTHON 021299 PAROXETINE MESYLATE Tablet; 30MG BASE PAROXETINE MESYLATE SYNTHON 021299 PAROXETINE MESYLATE Tablet; 40MG BASE PAROXETINE MESYLATE SYNTHON Paxil CR (paroxetine HCl) Controlled-Release Tablets, GlaxoSmithKline Paroxetine Hydrochloride Tablets, Sandoz, Inc., Paroxetine Hydrochloride Tablets, Alphapharm Paroxetine Hydrochloride Tablets, Sandoz, Inc. Paxil (paroxetine HCl) Imm ediate-Release & Controlled-Release Tablets, GlaxoSmithKline Paxil (paroxetine hydrochloride) Controlled Release Tablets, Glaxo SmithKline Paxil (paroxetine hydrochloride) Immediate Release Tablets, Glaxo SmithKline Pexeva (paroxetine mesylate) Tablets, Synthon Pharmaceuticals, Labeling Revision | Paxil (paroxetine hydrochloride) Immediate Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Controlled ReleaseTablets, GlaxoSmithKline, Labeling Revision | Pexeva [paroxetine (as mesylate)] Tablets, Synthon Pharmaceuticals, Labeling Revision | Paxil (paroxetine hydrochloride) Immediate Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Controlled Release Tablets, GlaxoSmithKline, Labeling Revision | Paroxetine Tablets, Teva Pharma, Approval| Paroxetine Tablets, Teva Pharma, Tentative Approval | Paxil (paroxetine hydrochloride) Immediate Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Controlled Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) CR , GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) suspension, GlaxoSmithKline, Labeling Revision | Paroxetine Hydrochloride Oral Suspension, Apotex Inc., Approval | Pexeva (paroxetine mesylate) Tablets, AAC/Kendle Consulting, New or Modified Indication | Paroxetine Hydrochloride Tablets, Roxane Labs, Tentative Approval | Paroxetine Tablets, Zydus Pharma, Approval | Paroxetine Hydrochloride Extended-Release Tablets, Mylan Labs, Tentative Approval | Paroxetine Hydrochloride Extended Release Tablets, Mylan Pharma, Approval | Paroxetine Hydrochloride Tablets, Caraco Pharma, Approval | Paroxetine Tablets, Teva Pharma, Approval | Paroxetine Tablets, Roxanne Labs, Approval | Paroxetine Tablets, Aurobindo Pharma, Approval | Paxil (paroxetine HCl) Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine HCl) Suspension, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine HCl) Controlled-Release Tablets, GlaxoSmithKline, Labeling Revision | Pexeva (paroxetine mesylate) Tablets, JDS Pharma, Labeling Revision | Pexeva (paroxetine mesylate) Tablets, JDS Pharma, Labeling Revision | Pexeva (paroxetine mesylate) Tablets, AAC/Kendle Consulting, Labeling Revision | Paroxetine Hydrochloride Tablets, Mylan Pharma, Approval | Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision | Pexeva (paroxetine mesylate) Tablets, Noven Pharmaceuticals, Inc., Labeling Revision | Paxil CR (paroxetine hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Manufacturing Change or Addition | Pexeva (paroxetine mesylate) Tablets, Noven Therapeutics, LLC, Labeling Revision | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision | Paxil CR (paroxetine hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision | Paxil CR (paroxetine hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Paroxetine Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval | Pexeva (paroxetine mesylate) Tablets, Noven Therapeutics, LLC, Labeling Revision | Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision | Paxil CR Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
  
|