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FDA Approval Activities for this Drug…
Bupropion Hydrochloride Extended-Release Tablets, 100 and 150 mg, Eon Labs Manufacturing, ANDA 75-932 1/24/02 4/10/03 | Bupropion Hydrochloride Tablets, 75 mg and 100 mg, Eon Labs Manufacturing, ANDA 75-613 10/10/00 11/7/00 12/5/01 | Bupropion Hydrochloride Tablets, 75 mg and 100 mg, Invamed ANDA 75-584 2/7/00 2/11/00 6/7/01 | Bupropion Hydrochloride Tablets, 75 mg and 100 mg, Mylan ANDA 75-491 Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, GlaxoSmithKline NDA 18-644/S-026 & 20-358/S-029 10/22/02 10/28/02 | Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, 75 mg and 100 mg & 100 mg and 150 mg respectively GlaxoSmithKline NDA 18-644/S-022/S-024 & 20-358/S-018/S-024 10/2/02 10/2/02 | Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, 75 mg and 100 mg & 100 mg and 150 mg respectively Glaxo SmithKline NDA 18-644/S-022/S-023 & 20-358/S-018/S-023 6/20/02 6/24/02 | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100 & 150 mg, GlaxoSmithKline NDA 20-358/S28 7/12/02 7/15/02 | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, Glaxo Wellcome NDA 20-358/S27 6/14/02 6/17/02 6/14/02 | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100 & 150 mg Glaxo Wellcome NDA 20-358/S25 2/13/02 | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100 & 150 mg Glaxo Wellcome NDA 20-358/S19 6/11/01 11/6/01 11/6/01 11/28/01 | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline NDA 21-515 8/28/03 09/09/03 | Wellbutrin (bupropion hydrochloride) Tablets GlaxoSmithKline NDA 18644/SCM-025 Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline NDA 20-711/S13, S14, S16 & S18 2/14/03 2/25/03 2/25/03 | Zyban (bupropion hydrochloride) extended-release tablets. GlaxoSmithKline NDA 20-711/S-015 2/21/02 2/21/02 | Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline NDA 20-711/S-012 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 100MG WELLBUTRIN SR GLAXOSMITHKLINE | 020358 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 150MG WELLBUTRIN SR GLAXOSMITHKLINE | 020711 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 150MG ZYBAN GLAXOSMITHKLINE | 020358 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 200MG WELLBUTRIN SR GLAXOSMITHKLINE | 020358 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 50MG WELLBUTRIN SR GLAXOSMITHKLINE | 021515 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 150MG WELLBUTRIN XL SMITHKLINE BEECHAM | 021515 BUPROPION HYDROCHLORIDE Tablet, Extended Release; 300MG WELLBUTRIN XL SMITHKLINE BEECHAM | 075613 BUPROPION HYDROCHLORIDE Tablet; 100MG BUPROPION HCL Eon 075613 BUPROPION HYDROCHLORIDE Tablet; 75MG BUPROPION HCL Eon 075584 BUPROPION HYDROCHLORIDE Tablet; 100MG BUPROPION HCL Geneva TECH | 075584 BUPROPION HYDROCHLORIDE Tablet; 75MG BUPROPION HCL Geneva TECH | 018644 BUPROPION HYDROCHLORIDE Tablet; 100MG WELLBUTRIN GLAXOSMITHKLINE | 018644 BUPROPION HYDROCHLORIDE Tablet; 75MG WELLBUTRIN GLAXOSMITHKLINE | 075491 BUPROPION HYDROCHLORIDE Tablet; 100MG BUPROPION HCL Mylan | 075491 BUPROPION HYDROCHLORIDE Tablet; 75MG BUPROPION HCL Mylan | 075310 BUPROPION HYDROCHLORIDE Tablet; 100MG BUPROPION HCL Teva | 075310 BUPROPION HYDROCHLORIDE Tablet; 75MG BUPROPION HCL Teva Bupropion Hydrochloride Extended-Release Tablets, Eon Labs Bupropion Hydrochloride Extended-Release Tablets, Impax Laboratories Bupropion Hydrochloride Extended-Release Tablets, Eon Labs | Bupropion Hydrochloride Extended-Release Tablets, Impax Laboratories Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline Bupropion Hydrochloride Extended-release Tablets, Impax Laboratories Wellbutrin Immediate Release Tablets, GlaxoSmithKline | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | ZYBAN (bupropion hydrochloride), GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets, Impax Labs, Approval | Wellbutrin Immediate Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets, Eon Labs, New Strength | Bupropion Hydrochloride Extended Release Tablets, Sandoz, Approval | Bupropion Hydrochloride Extended Release Tablets, Sandoz, Approval | Bupropion Hydrochloride Extended-Release Tablets, Anchen Pharma, Tentative Approval | Bupropion Hydrochloride Tablets, Apotex Inc., Approval | Wellbutrin Immediate Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, New or Modified Indication | Wellbutrin Immediate Release Tablets GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Bupropion Extended-Release Tablets, Anchen Pharma, Approval | Wellbutrin (bupropion HCl) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion HCl) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-release Tablets, Watson Labs, Tentative Approval | Zyban (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets (300mg), Watson Labs, Approval | Bupropion Hydrochloride Extended-Release Tablets (150mg), Watson Labs, Tentative Approval | Wellbutrin (bupropion HCl) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion HCl) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion HCl) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Zyban (bupropion HCl) Extended-Release Tablet, GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets, Actavis, Approval | Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Biovail Labs, Approval | Aplenzin (Bupropion Hydrobromide) Extended-release Tablets, Biovail Labs, Approval | Bupropion Hydrochloride Extended-Release Tablets, Actavis South Atlantic, LLC, Approval | Bupropion Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Control Supplement, Labeling | Bupropion Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Control Supplement, Labeling | Bupropion Hydrochloride Extended-Release Tablets, IMPAX Laboratories, Inc., Control Supplement, Labeling | Bupropion Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Approval | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision | Zyban (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision | Zyban (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets, Sun Pharmaceutical Industries, Inc., Approval | Bupropion Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval | Bupropion Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval | Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval | Bupropion Hydrochloride Extended-Release Tablets, Actavis South Atlantic LLC, Approval | Zyban (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Valeant Pharmaceuticals, Labeling Revision | Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision | Bupropion Hydrochloride Extended-Release Tablets, Anchen Pharmaceuticals, Inc., Approval | Bupropion Hydrochloride Extended-release Tablets (150mg), Anchen Pharmaceuticals, Inc., Approval | Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin SR (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision | Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Valeant Pharmaceuticals, Labeling Revision | Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Valeant Pharmaceuticals, Labeling Revision | Zyban (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Forfivo XL (bupropion hydrochloride) Extended-Release Tablets, IntelGenx Corp., Labeling Revision
  
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