Application Nr Approved Date Route Status External Links
ANDA090797 2011-02-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Pantoprazole Sodium Delayed-Release Tablets, Usp Are Indicated For: Pantoprazole Sodium Delayed-Release Is 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 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 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 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. Ammonia AMMONIA Molecular
2. Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER Unresolved
3. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
6. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
7. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
8. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Sodium Carbonate SODIUM CARBONATE Molecular BC-Boiler compound , B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
11. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
13. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
14. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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