FDA Approval Activities for this Drug…

Prevacid (lansoprazole) SoluTab Orally Desintegrating Delayed-Release, Capsules & Suspension, 15 & 30 mg, TAP Pharmaceutical Products, NDA 21-428, 20-406/S-052 & 21-281/S-007 8/30/02 9/12/02 9/5/02 Prevacid (lansoprazole) Delayed-Release Capsules, 15 & 30 mg, TAP Pharmaceutical Products, NDA 20-406/S-047 7/31/02 8/6/02 8/5/02 Prevacid (lansoprazole) Delayed-Release Capsules, Tap Pharmaceutical Products, NDA 20-406/S-034 6/8/01 Prevacid (lansoprazole) Delayed-Release Capsules,15 mg & 30 mg, Tap Pharmaceutical Products, NDA 20-406/S-033 11/30/00 12/20/00 12/20/00 Prevacid Indication: 1) for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use; and 2) for reducing the risk of NSAID-associated gastric ulcers in patients with history of documented gastric ulcer who require the use of a NSAID. Prevacid (lansoprazole) Delayed-Release Capsules Tap Holdings NDA 20-406/SE4-028 7/6/99 7/28/99 11/12/98 Prevacid Indication: Revision of the CLINICAL STUDIES section of the package insert to add information regarding a superiority claim over ranitidine for day and night heartburn. Prevacid (lansoprazole) Delayed-Release Capsules Tap Holdings NDA 20-406/S-027 & 20-406/S-030 1/14/99 7/5/01 Prevacid (lansoprazole) Delayed-Release Capsules Tap Holdings NDA 20-406/S-021 7/14/98 7/20/98 12/29/98 Prevacid (lansoprazole) Delayed-Release Capsules Tap Holdings NDA 20-406/S-016 3/12/98 11/12/98 Prevacid (lansoprazole) Delayed-Release Capsules Tap Holdings NDA 20-406/S-038 5/1/01 4/24/03 Prevacid (lansoprazole) Delayed-Release Capsules & Suspension, TAP Pharmaceutical Products, NDA 20-406/S-048 & 21-281/S-004 12/3/02 12/9/02 Prevacid (lansoprazole) Delayed-Release Suspension, TAP Pharmaceutical Products, NDA 20-406/S-045 & 21-281/S-002 5/3/02 5/9/02 5/6/02 Prevacid (lansoprazole) Delayed-Release Suspension, 15 mg & 30 mg, TAP Pharmaceutical Products, NDA 21-281 Prevpac (Lansoprazole, Amoxicillin,& Clarithromycin) Capsules, Capsules & Tablets, 30, 500 & 500 mg respectively, TAP Pharmaceutical Products, NDA 50-757/S6 & 8 11/22/02 12/9/02 11/25/02 Prevpac (Lansoprazole Delayed-Release Capsules, clarithromycin Ta and amoxicillin) Capsules, TAP Holdings, NDA 50-757/S-004 10/22/99 4/29/02 4/29/02 4/29/02 Prevpac (lansoprazole, clarithromycin and amoxicillin) Capsules, TAP Holdings, NDA 50-757/S-003 8/20/99 4/29/02 4/29/02 4/29/02 Prevpac (lansoprazole, clarithromycin and amoxicillin), TAP Holdings, NDA 50-757/S-002 1/22/99 2/5/99 2/5/99 4/23/02 Prevpac Indication: Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence. This efficacy supplement changed the duration of treatment with lansoprazole from 14 to 10 days and included recent minor changes to the clarithromycin labeling. AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE Capsule, Tablet, Capsule, Delayed Rel Pellets; 500MG;500MG;30MG PREVPAC TAP 020406 LANSOPRAZOLE Capsule, Delayed Rel Pellets; 15MG PREVACID TAP 020406 LANSOPRAZOLE Capsule, Delayed Rel Pellets; 30MG PREVACID TAP 021281 LANSOPRAZOLE For Suspension, Extended Release; 15MG/PACKET PREVACID TAP 021281 LANSOPRAZOLE For Suspension, Extended Release; 30MG/PACKET PREVACID TAP 021428 LANSOPRAZOLE Tablet, Orally Disintegrating; 15MG PREVACID TAP 021428 LANSOPRAZOLE Tablet, Orally Disintegrating; 30MG PREVACID TAP Prevacid Naprapac (Lansoprazole/Naproxen) Delayed-Release Capsule/Tablet, TAP Pharmaceutical Prevacid (lansoprazole) Delayed-Release Capsules, TAP Pharmaceutical Prevacid (lansoprazole) For Delayed-Release Oral Suspension, TAP Pharmaceutical Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablet, TAP Pharmaceutical PrevPac (Lansoprazole/Amoxicillin/Clarithromycin), TAP Pharmaceutical, Labeling Revision | Prevacid IV (lansoprazole) Injection, TAP Pharmaceutical, Labeling Revision | PREVPAC (lansoprazole/amoxicillin/clarithromycin), TAP Pharma, Labeling Revision

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