Application Nr Approved Date Route Status External Links
ANDA077056 2007-08-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pantoprazole Sodium Delayed-Release Tablets Are Indicated For: Pantoprazole Sodium Delayed-Release Tablets Are A Proton Pump Inhibitor Indicated For The Following: Short-Term Treatment Of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (gerd) (1.1) Maintenance Of Healing Of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3) 1.1 Short-Term Treatment Of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (gerd) Pantoprazole Sodium Delayed-Release Tablets Are Indicated In Adults For The Short-Term Treatment (up To 8 Weeks) In The Healing And Symptomatic Relief Of Erosive Esophagitis. For Those Adult Patients Who Have Not Healed After 8 Weeks Of Treatment, An Additional 8 Week Course Of Pantoprazole Sodium Delayed-Release Tablets May Be Considered. Safety Of Treatment Beyond 8 Weeks In Pediatric Patients Has Not Been Established. Pediatric Indication And Usage Information In Pediatric Patients Ages Five Years And Older With Erosive Esophagitis Associated With Gerd Is Approved For Wyeth Pharmaceuticals Inc.’s Pantoprazole Sodium Delayed-Release Tablets. However, Due To Wyeth Pharmaceuticals Inc.’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. 1.2 Maintenance Of Healing Of Erosive Esophagitis Pantoprazole Sodium Delayed-Release Tablets Are Indicated For Maintenance Of Healing Of Erosive Esophagitis And Reduction In Relapse Rates Of Daytime And Nighttime Heartburn Symptoms In Adult Patients With Gerd. Controlled Studies Did Not Extend Beyond 12 Months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole Sodium Delayed-Release Tablets Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome.

All Formulated Excipients (14 Total)

Name Structure Kind Function Status
1. Calcium Carbonate CALCIUM CARBONATE Molecular DS-Dietary supplement , DYE-Dye , EMUL-Emulsifier , MISC-Miscellaneous , NUTR-Nutrient GRAS-Generally recognized as safe.
2. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
5. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
11. Sodium Carbonate SODIUM CARBONATE Molecular BC-Boiler compound , B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
12. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
13. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pantoprazole Sodium PANTOPRAZOLE SODIUM ZINC4099200

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