Application Nr Approved Date Route Status External Links
ANDA077619 2011-01-19 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 Indicated For: Pantoprazole Sodium 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 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 (18 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
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. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
6. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
7. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
8. Methylated Spirits METHYLATED SPIRITS Unresolved
9. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
10. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
12. Shellac SHELLAC Unresolved
13. Sodium Carbonate SODIUM CARBONATE Molecular BC-Boiler compound , B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
14. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
15. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
16. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
17. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
18. Zein ZEIN Unresolved

Active Ingredients ( 1 Total)

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

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