Application Nr Approved Date Route Status External Links
ANDA204228 2016-07-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Omeprazole And Sodium Bicarbonate Capsules Are A Proton Pump Inhibitor Indicated For: Short-Term Treatment Of Active Duodenal Ulcer (1.1) Short-Term Treatment Of Active Benign Gastric Ulcer (1.2) Treatment Of Gastroesophageal Reflux Disease (gerd) (1.3) Maintenance Of Healing Of Erosive Esophagitis (1.4) The Safety And Effectiveness Of Omeprazole And Sodium Bicarbonate Capsules In Pediatric Patients (<18 Years Of Age) Have Not Been Established. (8.4) 1.1 Duodenal Ulcer Omeprazole And Sodium Bicarbonate Capsules Are Indicated For Short-Term Treatment Of Active Duodenal Ulcer. Most Patients Heal Within Four Weeks. Some Patients May Require An Additional Four Weeks Of Therapy. [see Clinical Studies (14.1).] 1.2 Gastric Ulcer Omeprazole And Sodium Bicarbonate Capsules Are Indicated For Short-Term Treatment (4-8 Weeks) Of Active Benign Gastric Ulcer. [see Clinical Studies (14.2).] 1.3 Treatment Of Gastroesophageal Reflux Disease (gerd) Symptomatic Gerd Omeprazole And Sodium Bicarbonate Capsules Are Indicated For The Treatment Of Heartburn And Other Symptoms Associated With Gerd For Up To 4 Weeks. [see Clinical Studies (14.3).] Erosive Esophagitis Omeprazole And Sodium Bicarbonate Capsules Are Indicated For The Short-Term Treatment (4-8 Weeks) Of Erosive Esophagitis Which Has Been Diagnosed By Endoscopy. The Efficacy Of Omeprazole And Sodium Bicarbonate Capsules Used For Longer Than 8 Weeks In These Patients Has Not Been Established. If A Patient Does Not Respond To 8 Weeks Of Treatment, It May Be Helpful To Give Up To An Additional 4 Weeks Of Treatment. If There Is Recurrence Of Erosive Esophagitis Or Gerd Symptoms (e.g., Heartburn), Additional 4-8 Week Courses Of Omeprazole And Sodium Bicarbonate Capsules May Be Considered. [see Clinical Studies (14.3).] 1.4 Maintenance Of Healing Of Erosive Esophagitis Omeprazole And Sodium Bicarbonate Capsules Are Indicated To Maintain Healing Of Erosive Esophagitis. Controlled Studies Do Not Extend Beyond 12 Months. [see Clinical Studies (14.4).]

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Shellac SHELLAC Unresolved

Active Ingredients ( 2 Total)

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