Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.