FDA Approval Activities for this Drug…

Amoxicillin Capsules 2 and , Ranbaxy 65-016 4/8/99 5/25/99 Amoxil (amoxicillin) Chewable & Powder Smith Kline Beecham 50-542/S-005, S-010, S-011 7/27/99 Amoxil (amoxicillin) chewable and SmithKline Beecham 50-760 4/16/99 4/27/99 4/27/99 Amoxil (amoxicillin) Teva USA 65-119 12/4/02 Amoxil (amoxicillin) Ranbaxy Ltd. 65-113 11/29/02 Amoxil (amoxicillin) SmithKline Beecham 50-761 4/16/99 4/27/99 4/27/99 Amoxicillin & Clavulanate Potassium Ranbaxy Ltd. 65-132 3/19/03 Amoxicillin & Clavulanate Potassium LEK 65-098 12/16/02 Amoxicillin and Clavulanate Potassium for /28./5 mL, and /5/5 mL, Geneva 65-066 6/5/02 4/9/03 Amoxicillin and Clavulanate Potassium /12, LEK 65-117 11/27/02 Amoxicillin and Clavulanate Potassium /12, Ranbaxy Ltd. 65-109 11/4/02 Amoxicillin & Clavulanate Potassium 87/12, Ranbaxy Ltd. 65-102 9/17/02 Amoxicillin & Clavulanate Potassium /12, Teva 65-101 10/30/02 Amoxicillin & Clavulanate Potassium 87/12, Teva 65-096 10/29/02 Amoxicillin & Clavulanate Potassium 87/12, LEK 65-093 11/21/02 Amoxicillin & Clavulanate Potassium /28.and /5, Geneva 65-065 4/18/02 4/9/03 Amoxicillin & Clavulanate Potassium /12, Geneva 65-064 3/15/02 10/10/02 Amoxicillin & Clavulanate Potassium 87/12, Geneva 65-063 3/14/02 10/10/02 Amoxicillin and , Ranbaxy 65-060 11/29/00 2/28/01 Amoxicillin and 87, Ranbaxy 65-059 11/24/00 11/27/00 1/15/02 1/15/02 Amoxicillin and 87, Teva 65-056 9/18/00 10/30/00 1/17/02 Amoxicillin USP,12 and 2 (Chewable). Ranbaxy 65-021 12/23/99 12/27/99 Amoxil (amoxicillin) Chewable GlaxoSmithKline 50-542/S-019, 50-754/S-004, 50-760/S-003, & 50-761/S-003 5/12/03 7/9/03 Amoxil (amoxicillin), GlaxoSmithKline 50-542/S-016 & 50-754/S-001 4/10/02 4/16/02 Amoxil (amoxicillin) and 87 SmithKline Beecham 50-754 Augmentin (amoxicillin/clavulanate potassium) GlaxoSmithKline 50-564/S43 & 50-720S15 7/25/03 8/15/03 Augmentin (amoxicillin/clavulanate potassium) GlaxoSmithKline 50-575/S-032, 50-597/S-039, 50-725/S-017 & 50-726/S-014 5/12/03 7/9/03 Augmentin (amoxicillin/clavulanate potassium) GlaxoSmithKline 50-564/S-034, 50-575/S-025, 50-597/S-030, 50-720/S-006, 50-725/S-004 & 50-726/S-004 4/10/02 4/16/02 Augmentin ES-600 (amoxicillin/clavulanate potassium) powder for oral GlaxoSmithKline 50-755/S-003 5/12/03 7/9/03 Augmintin XR (Amoxicillin/Clavulanate Potassium) Extended-release /62., GlaxoSmithKline 50-785 9/25/02 10/2/02 9/27/02 7/6/03 Augmintin ES (Amoxicillin/Clavulanate Potassium) GlaxoSmithKline 50-755 DisperMox (Amoxicillin) for Ranbaxy 65-080 Amoxicillin and Clavulanate Potassium Ranbaxy Laboratories Ltd. Amoxil (amoxicillin) Chewable Tablets, Tablets, & Oral Suspension, GlaxoSmithKline Amoxicillin and Clavulanate Potassium Powder Oral Suspension USP, Teva Pharmaceuticals Amoxicillin and Clavulanate Potassium for Oral Suspension USP Powder Oral Suspension, Teva Pharmacecuticals Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablet, GlaxoSmithKline AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline Augmentin (amoxicillin/clavulanate potassium) Powder for Oral suspension, GlaxoSmithKline Augmentin ES-600 (amoxicillin/clavulanate potassium) for Oral Suspension, GlaxoSmithKline PrevPac (Lansoprazole/Amoxicillin/Clarithromycin), TAP Pharmaceutical, Labeling Revision Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision Augmentin (amoxicillin/clavulanate potassium) Powder for Oral suspension, GlaxoSmithKline, Labeling Revision AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision | Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets, GlaxoSmithKline, Labeling Revision | Augmentin ES-600 (amoxicillin/clavulanate potassium) Oral Suspension, GlaxoSmithKline, Labeling Revision | Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Patient Population Altered | Amoxicillin & Clavulanate Potassium Oral Suspension, Hikma Pharma, Approval | Amoxicillin and Clavulante Potassium Tablets, Teva Pharma, Approval | PREVPAC (lansoprazole/amoxicillin/clarithromycin), TAP Pharma, Labeling Revision

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