Application Nr Approved Date Route Status External Links
ANDA205119 2016-01-26 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, Usp 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, Usp Are Indicated In Adults And Pediatric Patients Five Years Of Age And Older 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, Usp May Be Considered. Safety Of Treatment Beyond 8 Weeks In Pediatric Patients Has Not Been Established. 1.2 Maintenance Of Healing Of Erosive Esophagitis Pantoprazole Sodium Delayed-Release Tablets, Usp 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, Usp 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. Ammonia AMMONIA Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
5. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
8. Povidones POVIDONES Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Shellac SHELLAC Unresolved
11. Sodium Carbonate SODIUM CARBONATE Molecular BC-Boiler compound , B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
12. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
13. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
14. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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