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FDA Approval Activities for this Drug…
Omeprazole Capsules, 10 mg & 20 mg, Genpharm ANDA 75-268 10/18/02 Omeprazole delayed-release Capsules, (40 mg ) Torpharm ANDA 76-048 10/6/03 Omeprazole delayed-release Capsules, 10 mg 20 & (40 mg ), Mylan ANDA 75-876 5/29/03 Omeprazole delayed-release Capsules, 10 mg & 20 mg, Eon Labs, ANDA 75-791 10/24/02 Omeprazole delayed-release Capsules, 10 mg & 20 mg, Eon Labs, ANDA 75-791 10/24/02 Omeprazole delayed-release Capsules, 10 & 20 mg, (40 mg dosage ) Impax, ANDA 75-785 11/8/02 Omeprazole delayed-release Capsules, 10 mg & 20 mg, LEK ANDA 75-757 1/28/03 Omeprazole delayed-release Capsules, 10 mg & 20 mg, Kremers Urban Development Co. ANDA 75-410 11/1/02 Omeprazole delayed-release Capsules, 10 mg & 20 mg, Kremers Urban Development Co. ANDA 75-410 5/3/01 6/5/01 Omeprazole delayed-release Capsules, 10 mg, 20 mg, & 40 mg, Andrx ANDA 75-347 11/16/01 12/18/01 Omeprazole delayed-release Capsules, 10 mg, 20 mg, & 40 mg, 3/23/00 Andrx ANDA 75-347 Prilosec (omeprazole magnesium) Delayed-Release Tablets, 20 mg, OTC Citizen Petition AstraZeneca LP NDA 21-229 6/20/03 6/20/03 6/20/03 Part 1, Part 2, Part 3 & Part 4 Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP NDA 019-810/S67 & S80 10/9/03 10/16/03 10/16/03 Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP NDA 019-810 / S76 12/16/02 1/29/03 Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP NDA 019-810 / S74 7/12/02 7/24/02 7/16/02 Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP NDA 019-810 / S62 2/23/00 6/8/01 Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP NDA 019-810 / S61 2/14/02 2/21/02 Prilosec (omeprazole) Delayed-Release Capsules, Astra Merck NDA 019-810 / S57 2/3/99 5/22/01 Prilosec (omeprazole) Delayed-Release Capsules, Astra Merck NDA 019-810 / S38 / S50 / S56 1/15/98 7/14/99 Prilosec Indication:Gastrogesophageal Reflux Disease. Prilosec (omeprazole) Delayed-Release Capsules, Astra Merck NDA 20-916 6/29/98 1/4/99 4/11/02 Prilosec Indication: for the eradication of H. pylori in patients with duodenal ulcer disease. OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG OMEPRAZOLE Andrx 075347 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG OMEPRAZOLE Andrx 075347 OMEPRAZOLE Capsule, Delayed Rel Pellets; 40MG OMEPRAZOLE Andrx 019810 OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG PRILOSEC ASTRAZENECA 019810 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG PRILOSEC ASTRAZENECA 019810 OMEPRAZOLE Capsule, Delayed Rel Pellets; 40MG PRILOSEC ASTRAZENECA 075791 OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG OMEPRAZOLE Eon 075791 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG OMEPRAZOLE Eon 075785 OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG OMEPRAZOLE Impax 075785 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG OMEPRAZOLE Impax 075410 OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG OMEPRAZOLE KREMERS URBAN DEV 075410 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG OMEPRAZOLE KREMERS URBAN DEV 075757 OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG OMEPRAZOLE LEK 075757 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG OMEPRAZOLE LEK 075876 OMEPRAZOLE Capsule, Delayed Rel Pellets; 10MG OMEPRAZOLE Mylan 075876 OMEPRAZOLE Capsule, Delayed Rel Pellets; 20MG OMEPRAZOLE Mylan Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP Zegerid (omeprazole) Powder, Santarus, Inc. | Prilosec OTC (20mg omeprazole) Tablets, Proctor & Gamble, Labeling Revision | Omeprazole Immediate-Release Powder for Oral Suspension, Santarus, Approval | PRILOSEC (omeprazole) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Prilosec (omeprazole) Delayed release Capsules, AstraZeneca, Labeling Revision | Omeprazole Delayed Release Capsules, Dr. Reddy’s Labs, Tentative Approval | Zegerid Capsules, Santarus, Approval (alert) | Zegerid (Omeprazole Sodium Bicarbonate) Capsules, Santarus, Approval | Zegerid Chewable Tablets, Santarus Inc., Approval | Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Prilosec OTC (omeprazole magnesium) delayed-release tablets, Procter & Gamble Co., Labeling Revision | Prilosec OTC (omeprazole magnesium) tablets, Procter & Gamble, Labeling Revision | Prilosec (omeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Omeprazole Delayed-Release Tablets, Dexcel Pharma, Tentative Approval | Omeprazole Delayed-Release Capsules, Lek Pharma, Tentative Approval | Omeprazole Delayed-release Capsules 10 & 20mg, Apotex, Approval | Omeprazole Delayed-release Capsules 10 & 20mg, Impax Labs, Approval | Omeprazole Delayed-release Capsules 10 & 20mg, Dr. Reddy’s Labs, Approval | Omeprazole Delayed-Release Tablets, Dexcel Pharma, Approval | Zegerid (omeprazole/sodium bicarbonate) Capsules, Santarus, Inc., Formulation Revision | Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, Proctor & Gamble, Labeling Revision | Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca, Package Change | Omeprazole Delayed-Release Capsules, Lek Pharm, Tentative Approval | Omeprazole Delayed-Release Capsules, Dr. Reddy's Laboratories, Ltd., Tentative Approval | Omeprazole Delayed-Release Capsules, Andrx Pharmaceuticals, LLC, Approval | Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Package Change
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