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FDA Approval Activities for this Drug…
Protonix I.V.(pantoprazole sodium) Injection, Wyeth-Ayerst NDA 20-988/S7 2/21/03 3/10/03
| Protonix I.V. (pantoprazole sodium) for Injection, equivalent to 40 mg, Wyeth-Ayerst NDA 20-988/S-003 Protonix I. V. (pantoprazole sodium) Injection, Wyeth-Ayerst NDA 20-988/S16 10/24/03
| Protonix I. V. (pantoprazole sodium) Injection, Wyeth-Ayerst NDA 20-988/S3 10/18/01 11/6/01 11/6/01
| Protonix I. V. (pantoprazole sodium) Injection, Wyeth-Ayerst NDA 20-988 3/22/01 4/4/02 4/4/02 4/4/02
| Protonix Indication: Short-term treatment (7 to 10 days) of gastroesophageal reflux disease GERD).
Protonix (pantoprazole sodium) Delayed-Release Tablets & IV, Wyeth NDA 20-987/SLR-013 & 20-988/SLR-012 10/28/02 10/30/02 4/9/03
| Protonix (pantoprazole sodium) Delayed-Release Tablets, 20 & 40 mg, Wyeth-Ayerst NDA 20-987/S7 4/19/02 5/2/02 4/22/02 7/31/02
| Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth-Ayerst NDA 20-987/S5 7/20/01 04/25/03
Protonix (pantoprazole sodium) Delayed-Release Tablets, 40 mg, Wyeth-Ayerst NDA 20-987S1 & S2 6/12/01 11/6/01
| Protonix Indication: Maintenance of Healing of Erosive Esophagitis and control of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD).
| Protonix (pantoprazole sodium) Delayed-Release Tablets Wyeth-Ayerst NDA 20-987 2/2/00 2/3/00 2/7/00 6/18/01
Protonix Indication: Short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease GERD). Protonix I. V. (pantoprazole sodium) Injection, Wyeth-Ayerst Protonix I.V.(pantoprazole sodium) Injection, Wyeth Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharmaceuticals, Inc. Protonix (pantoprazole) Delayed-Release Tablets, Wyeth Pharmaceuticals
| Protonix I.V.(pantoprazole sodium) Injection, Wyeth Pharmaceuticals Protonix (pantoprazole) Delayed-Release Tablets, Wyeth Pharmaceuticals Protonix I. V. (pantoprazole sodium) Injection, Wyeth Pharmaceuticals Protonix (PANTOPRAZOLE) I.V., Wyeth Pharmaceuticals | Protonix I.V. (pantoprazole) Injection, Wyeth Pharma, Control Supplement | Protonix I.V. (pantoprazole sodium) Injection, Wyeth Pharma, Labeling Revision | Protonix (pantoprazole) Delayed-Release Tablets, Wyeth Pharma, Labeling Revision | Protonix I.V. (pantoprazole) Injection, Wyeth Pharma, New or Modified Indication | Protonix I.V. (pantoprazole sodium) Injection, Wyeth Pharma, Labeling Revision | Protonix I.V. (pantoprazole sodium) Injection, Wyeth Pharma, Control Supplement | Pantoprazole Sodium Delayed-Release Tablets, Teva Pharma, Tentative Approval | Pantoprazole Sodium Delayed-Release Tablets, Sandoz Inc., Tentative Approval | Pantoprazole Sodium Delayed-Release Tablets, Sun Pharma, Tentative Approval | Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharma, Labeling Revision | Pantoprazole Sodium Delayed-Release Tablets, Teva Pharma, Approval | Pantoprazole Sodium Delayed Release Tablet, Sun Pharma, Approval | Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharma, Approval | Pantoprazole Sodium, Extended Release Tablet, Dr. Reddy's Labs, Tentative Approval | Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharma, Labeling Revision | Protonix I.V. (pantoprazole sodium) Injection, Wyeth Pharma, Labeling Revision | Pantoprazole Sodium Injection, Teva Parenteral, Tentative Approval | Pantoprazole Sodium Delayed-Release Tablets, KUDCO Ireland Limited, Approval | Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharmaceuticals, Labeling Revision | Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharmaceuticals, Labeling Revision & Patient Population Altered | Protonix (pantoprazole sodium) Delayed-Release Oral Solution, Pfizer, Labeling Revision | Protonix (pantoprazole sodium) Delayed-Release Tablets, Pfizer, Labeling Revision | Protonix I.V. (pantoprazole sodium) I.V. Injection, Pfizer, Labeling Revision | Pantoprazole Sodium Delayed Release Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval | Pantoprazole Sodium Delayed-Release Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval | Pantoprazole Sodium Delayed-Release Tablets, Dr. Reddy’s Laboratories, Ltd., Approval | Pantoprazole Sodium Delayed-Release Tablets, Kudco Ireland, Ltd., Approval | Pantoprazole Sodium Delayed-Release Tablets, Matrix Laboratories, Ltd., Approval | Pantoprazole Sodium Delayed-Release Tablets, Torrent Pharmaceuticals, Ltd., Approval | Pantoprazole Sodium Delayed-Release Tablets, Wockhardt, Ltd., Approval | Pantoprazole Sodium Delayed-Release Tablets, Actavis Totowa LLC, Approval | Protonix I.V. (pantoprazole sodium) Injection, Pfizer, Inc., Labeling Revision | Protonix (pantoprazole sodium) Delayed-Release Tablets, Pfizer, Inc., Labeling Revision | Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension, Pfizer, Inc., Labeling Revision | Protonix IV (pantoprazole sodium) I.V. Injection, Wyeth Pharmaceuticals Inc., Labeling Revision | Pantoprazole Sodium Delayed-Release Tablets, Jubilant Organosys Ltd, Approval | Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharmaceuticals, Inc., Labeling Revision | Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision | Protonix IV (pantoprazole sodium) I.V. Injection, Wyeth Pharmaceuticals Inc., Labeling Revision
  
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