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FDA Approval Activities for this Drug…
Aleve (naproxen sodium) Tablets, Capsules & Gelcaps, 220 mg, Bayer Consumer Care Division NDA 20-204/S-016 8/30/02 9/11/02 | Aleve (naproxen sodium), Bayer Consumer Care Division NDA 20-204/S-008 3/19/02 3/29/02 | Aleve (naproxen sodium), 220mg. Bayer Consumer Care Division NDA 20-204/S-007 3/6/01 5/1/01 | Aleve Cold and Sinus ( naproxen sodium & pseudoephadrine hydrochloride extended-release tablet), 220mg/120mg Bayer NDA 21-076/S7 7/31/02 8/6/02 | Aleve Cold and Sinus ( naproxen sodium & pseudoephadrine hydrochloride extended-release tablet), 220mg/120mg Bayer NDA 21-076 Naprosyn (naproxen), Suspension and Anaprox (naproxen sodium), Syntex Development Research NDA 17-581/S-098, 18-965/S-007 & 18-164/S-049 4/14/03 | Naproxen Delayed-release Tablets, 375 mg & 500 mg. Purepac Pharmaceutical Co. ANDA 74-936 2/24/98 3/19/99 | Naproxen Tablets, 250 mg, 375 mg and 500 mg, Interpharm, ANDA 75-927 12/18/01 | Naproxen Delayed-release Tablets, 375 mg and 500 mg, Alphapharm Pty. Ltd. ANDA 75-390 4/19/01 4/24/01 12/17/01 | Naproxen Delayed-release Tablets, 375 mg and 500 mg, Alphapharm Pty. Ltd. ANDA 75-390 4/19/01 4/24/01 12/17/01 | Naproxen Delayed-release Tablets, 375 mg and 500 mg, Sidmak , ANDA 75-337 5/26/99 6/1/99 | Naproxen Delayed-release Tablets, 375 mg and 500 mg, Teva ANDA 75-227 6/30/98 6/30/98 | Naproxen Delayed-release Tablets, 375 mg & 500 mg. Invamed, ANDA 75-061 2/18/98 3/19/99 | Naproxen Sodium Extended-release Tablets, 375 & 500 mg, Andrx ANDA 75-416/S2, S3 4/23/03 | Naproxen Sodium Extended-release Tablets, 500 mg, Andrx ANDA 75-416 8/27/02 | Naproxen Sodium Extended-release Tablets, 375 mg and 500 mg, 7/5/2001 Andrx ANDA 75-416 7/5/01 | Naproxen Sodium Extended-release Tablets, 500 mg (base), 3/17/00 Andrx ANDA 75-416 3/17/00 3/21/00 | Naproxen Sodium Tablets, 275 & 550 mg, Able ANDA 76-544 8/22/03 | Naproxen Sodium Tablets, 220 mg (200 mg base), OTC Par Pharmaceutical ANDA 75-168 NAPROXEN Suspension; 25MG/ML NAPROSYN ROCHE PALO | 074190 NAPROXEN Suspension; 25MG/ML NAPROXEN Roxane | 075061 NAPROXEN Tablet, Delayed Release; 375MG NAPROXEN Geneva TECH | 075061 NAPROXEN Tablet, Delayed Release; 500MG NAPROXEN Geneva TECH | 075337 NAPROXEN Tablet, Delayed Release; 375MG NAPROXEN Pliva | 075337 NAPROXEN Tablet, Delayed Release; 500MG NAPROXEN Pliva | 074936 NAPROXEN Tablet, Delayed Release; 375MG NAPROXEN Purepac | 074936 NAPROXEN Tablet, Delayed Release; 500MG NAPROXEN Purepac 020067 NAPROXEN Tablet, Delayed Release; 375MG EC-NAPROSYN ROCHE PALO | 020067 NAPROXEN Tablet, Delayed Release; 500MG EC-NAPROSYN ROCHE PALO | 075227 NAPROXEN Tablet, Delayed Release; 375MG NAPROXEN Teva | 075227 NAPROXEN Tablet, Delayed Release; 500MG NAPROXEN Teva | 075390 NAPROXEN Tablet, Extended Release; 375MG NAPROXEN Alphapharm | 075390 NAPROXEN Tablet, Extended Release; 500MG NAPROXEN Alphapharm | 074410 NAPROXEN Tablet; 250MG NAPROXEN CLONMEL | 074410 NAPROXEN Tablet; 375MG NAPROXEN CLONMEL | 074410 NAPROXEN Tablet; 500MG NAPROXEN CLONMEL | 074207 NAPROXEN Tablet; 250MG NAPROXEN Copley | 074207 NAPROXEN Tablet; 375MG NAPROXEN Copley | 074207 NAPROXEN Tablet; 500MG NAPROXEN Copley | 074140 NAPROXEN Tablet; 250MG NAPROXEN Geneva | 074140 NAPROXEN Tablet; 375MG NAPROXEN Geneva | 074140 NAPROXEN Tablet; 500MG NAPROXEN Geneva | 075927 NAPROXEN Tablet; 250MG NAPROXEN Interpharm | 075927 NAPROXEN Tablet; 375MG NAPROXEN Interpharm | 075927 NAPROXEN Tablet; 500MG NAPROXEN Interpharm | 074111 NAPROXEN Tablet; 250MG NAPROXEN Ivax | 074111 NAPROXEN Tablet; 375MG NAPROXEN Ivax | 074111 NAPROXEN Tablet; 500MG NAPROXEN Ivax | 074105 NAPROXEN Tablet; 250MG NAPROXEN LEDERLE | 074105 NAPROXEN Tablet; 375MG NAPROXEN LEDERLE | 074105 NAPROXEN Tablet; 500MG NAPROXEN LEDERLE | 074121 NAPROXEN Tablet; 250MG NAPROXEN Mylan | 074121 NAPROXEN Tablet; 375MG NAPROXEN Mylan | 074121 NAPROXEN Tablet; 500MG NAPROXEN Mylan | 074182 NAPROXEN Tablet; 250MG NAPROXEN Pliva | 074182 NAPROXEN Tablet; 375MG NAPROXEN Pliva | 074182 NAPROXEN Tablet; 500MG NAPROXEN Pliva | 074263 NAPROXEN Tablet; 250MG NAPROXEN Purepac | 074263 NAPROXEN Tablet; 375MG NAPROXEN Purepac | 074263 NAPROXEN Tablet; 500MG NAPROXEN Purepac | 017581 NAPROXEN Tablet; 250MG NAPROSYN ROCHE PALO | 017581 NAPROXEN Tablet; 375MG NAPROSYN ROCHE PALO | 017581 NAPROXEN Tablet; 500MG NAPROSYN ROCHE PALO | 074211 NAPROXEN Tablet; 250MG NAPROXEN Roxane | 074211 NAPROXEN Tablet; 375MG NAPROXEN Roxane | 074211 NAPROXEN Tablet; 500MG NAPROXEN Roxane | 074216 NAPROXEN Tablet; 250MG NAPROXEN Teva | 074129 NAPROXEN Tablet; 250MG NAPROXEN Teva | 074201 NAPROXEN Tablet; 250MG NAPROXEN Teva | 074201 NAPROXEN Tablet; 375MG NAPROXEN Teva | 074129 NAPROXEN Tablet; 375MG NAPROXEN Teva | 074216 NAPROXEN Tablet; 375MG NAPROXEN Teva | 074216 NAPROXEN Tablet; 500MG NAPROXEN Teva | 074129 NAPROXEN Tablet; 500MG NAPROXEN Teva | 074201 NAPROXEN Tablet; 500MG NAPROXEN Teva | 074457 NAPROXEN Tablet; 250MG NAPROXEN Watson | 074163 NAPROXEN Tablet; 250MG NAPROXEN Watson | 074163 NAPROXEN Tablet; 375MG NAPROXEN Watson | 074457 NAPROXEN Tablet; 375MG NAPROXEN Watson | 074457 NAPROXEN Tablet; 500MG NAPROXEN Watson | 074163 NAPROXEN Tablet; 500MG NAPROXEN Watson | 075416 NAPROXEN SODIUM Tablet, Extended Release; 375MG BASE NAPROXEN SODIUM Andrx | 075416 NAPROXEN SODIUM Tablet, Extended Release; 500MG BASE NAPROXEN SODIUM Andrx 020353 NAPROXEN SODIUM Tablet, Extended Release; 375MG BASE NAPRELAN ELAN 020353 NAPROXEN SODIUM Tablet, Extended Release; 500MG BASE NAPRELAN ELAN | 076544 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Able | 076544 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Able | 074480 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM AL Hikma | 074480 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM AL Hikma | 074289 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Copley | 074289 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Copley | 074162 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Geneva | 074162 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Geneva | 074495 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Geneva TECH 074495 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Geneva TECH 074230 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Ivax | 074230 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Ivax | 074367 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Mylan | 074367 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Mylan | 074242 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Pliva | 074242 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Pliva | 018164 NAPROXEN SODIUM Tablet; 250MG BASE ANAPROX ROCHE PALO | 018164 NAPROXEN SODIUM Tablet; 500MG BASE ANAPROX DS ROCHE PALO | 074257 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Roxane | 074257 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Roxane | 074198 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Teva | 074142 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Teva | 074142 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Teva | 074198 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Teva | 074195 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Watson | 074455 NAPROXEN SODIUM Tablet; 250MG BASE NAPROXEN SODIUM Watson | 074455 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Watson | 074195 NAPROXEN SODIUM Tablet; 500MG BASE NAPROXEN SODIUM Watson Prevacid Naprapac (Lansoprazole/Naproxen) Delayed-Release Capsule/Tablet, TAP Pharmaceutical Naproxen Tablets, West-Ward Pharmaceutical Naproxen Sodium Pseudoephedrine Extended-Release Tablets, L. Perrigo Co. Aleve (naproxen sodium) Tablets, Bayer HealthCare LLC | Naprosyn (naproxen) Tablets, Roche Palo Alto, Labeling Revision | Anaprox/Anaprox DS (naproxen sodium) Tablets, Roche Palo Alto, Labeling Revision | Naprosyn (naproxen) Suspension, Roche Palo Alto, Labeling Revision | EC-Naprosyn (naproxen) Delayed Release Tablets, Roche Palo Alto, Labeling Revision | Naproxen Tablets, Perrigo R&D Co., Approval | Midol Extended Relief (naproxen sodium) tablets, Bayer Healthcare, Labeling Revision | Aleve Cold & Sinus Extended Release Tablets, Bayer HealthCare, Labeling Revision | Aleve Tablets & Midol Extended Release Tablets, Bayer, Labeling Revision | Naprelan (naproxen sodium) Controlled-Release Tablets, Stat-Trade, Labeling Revision | Anaprox /Anaprox DS (naproxen sodium tablets), Hoffman- La Roche, Labeling Revision | Naprosyn (naproxen tablets), Hoffman- La Roche, Labeling Revision | Naprosyn (naproxen suspension), Hoffman- La Roche, Labeling Revision | EC Naprosyn (naproxen delayed-release tablets), Hoffman- La Roche, Labeling Revision | Naproxen Sodium Capsules, Banner Pharmacaps, Approval | Naprosyn (naproxen) tablets, Hoffman-La Roche, Labeling Revision | Anaprox/Anaprox DS (naproxen sodium) tablets, Hoffman-La Roche, Labeling Revision | Naprosyn (naproxen) Suspension, Hoffman-La Roche, Labeling Revision | Naprosyn EC (naproxen) delayed-release tablets, Hoffman-La Roche, Labeling Revision | Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy’s Labs, Approval | Naproxen Tablets, Glenmark Pharma, Approval | Anaprox/Anaprox DS (naproxen sodium) Tablets, Hoffmann-La Roche, Labeling Revision | EC-Naprosyn (naproxen) Delayed-Release Tablets, Hoffmann-La Roche, Labeling Revision | Naprosyn (naproxen) Tablets, Hoffmann-La Roche, Labeling Revision | Naprosyn (naproxen) Suspension, Hoffmann-La Roche, Labeling Revision | Naproxen Sodium Tablets, Glenmark Pharma, Approval | Naproxen Sodium Tablets, Interpharm Inc., Approval | Naprelan (naproxen sodium) Extended-Release Tablet, Stat-Trade Inc., Labeling Revision | Naproxen Tablets, Zydus Pharma, Approval | Naproxen Sodium Tablets, Dr. Reddy’s Labs, Approval | Treximet (sumatriptan, naproxen sodium) Tablets, Prozen Inc., Approval | Anaprox (naproxen sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision | Anaprox DS (naproxen sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision | EC-Naprosyn (naproxen) Delayed-Release Tablets, Hoffmann-La Roche, Inc., Labeling Revision | Naprosyn (naproxen) Tablets, Hoffmann-La Roche, Inc., Labeling Revision | Vimovo (naproxen/esomeprazole) | Naprosyn (naproxen) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision | Aleve Cold and Sinus (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer Healthcare, LLC, Labeling Revision | Prevacid NapraPac (lansoprazole and naproxen) Delayed-Release Capsules and Naproxen Tablets Kit, Takeda Pharmaceuticals North America, Inc., Labeling Revision | Aleve (naproxen sodium) Tablets, Bayer HealthCare LLC, Labeling Revision | Naproxen Sodium Tablets, Amneal Pharmaceuticals LLC, Approval | Aleve-D Sinus & Cold (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer HealthCare Consumer Care, Labeling Revision | Aleve (naproxen sodium) Tablets, Bayer HealthCare LLC, Labeling Revision | Aleve Liquid Gels (naproxen sodium) Capsules, Banner Pharmacaps Inc., Labeling Revision | Aleve (naproxen sodium) Capsules, Banner Pharmacaps, Inc., Labeling Revision | Aleve (naproxen sodium) Tablets, Bayer HealthCare, LLC, Labeling Revision | Sumatriptan and Naproxen Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Tentative Approval | Sumatriptan and Naproxen Sodium Tablets, Par Pharmaceutical Inc., Tentative Approval | Naproxen Tablets, Marksans Pharma Ltd., Approval | Aleve (naproxen sodium) Tablets, Bayer Healthcare, LLC, Labeling Revision | Naproxen Sodium Tablets, Marksans Pharma, Ltd., Approval | Aleve (naproxen sodium) Tablets, Bayer Healthcare LLC, Labeling Revision | Naproxen Sodium Tablets, Ranbaxy Laboratories Limited, Approval | Vimovo (naproxen/esomeprazole magnesium) Tablet, AstraZeneca LP, Labeling Revision | Naproxen Tablets, Invagen Pharmaceuticals, Inc., Approval | Naproxen Sodium Tablets, Granules India Ltd., Approval | Naproxen Delayed-Release Tablets, Invagen Pharmaceuticals, Inc., Approval | Treximet (naproxen sodium and sumatriptan succinate) Tablets, GlaxoSmithKline, Labeling Revision | Naproxen Sodium Tablets, Aurobindo Pharma Ltd., Approval | Naprelan (naproxen sodium) Controlled-Release Tablets, Stat-Trade, Inc., Labeling Revision | Naproxen Tablets, Aurobindo Pharmaceuticals USA, Inc., Approval | Treximet (naproxen sodium and sumatriptan succinate) Tablets, GlaxoSmithKline, Labeling Revision | VIMOVO (naproxen and esomeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Labeling Revision
  
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