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

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