Application Nr Approved Date Route Status External Links
ANDA078003 2015-01-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Esomeprazole Magnesium Delayed-Release Capsules Usp Are A Proton Pump Inhibitor Indicated For The Following: Treatment Of Gastroesophageal Reflux Disease (gerd) ( ) • 1.1 Risk Reduction Of Nsaid-Associated Gastric Ulcer ( ) • 1.2 Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence ( ) • H. Pylori 1.3 Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( ) • 1.4 1.1 Treatment Of Gastroesophageal Reflux Disease (gerd) Healing Of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules Usp Are Indicated For The Short-Term Treatment (4 To 8 Weeks) In The Healing And Symptomatic Resolution Of Diagnostically Confirmed Erosive Esophagitis. For Those Patients Who Have Not Healed After 4 To 8 Weeks Of Treatment, An Additional 4 To 8 Week Course Of Esomeprazole Magnesium Delayed-Release Capsules Usp May Be Considered. Maintenance Of Healing Of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules Usp Are Indicated To Maintain Symptom Resolution And Healing Of Erosive Esophagitis. Controlled Studies Do Not Extend Beyond 6 Months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole Magnesium Delayed-Release Capsules Usp Are Indicated For Short-Term Treatment (4 To 8 Weeks) Of Heartburn And Other Symptoms Associated With Gerd In Adults And Children 1 Year Or Older. 1.2 Risk Reduction Of Nsaid-Associated Gastric Ulcer Esomeprazole Magnesium Delayed-Release Capsules Usp Are Indicated For The Reduction In The Occurrence Of Gastric Ulcers Associated With Continuous Nsaid Therapy In Patients At Risk For Developing Gastric Ulcers. Patients Are Considered To Be At Risk Due To Their Age (≥ 60) And/or Documented History Of Gastric Ulcers. Controlled Studies Do Not Extend Beyond 6 Months. 1.3 Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence H. Pylori Triple Therapy (esomeprazole Magnesium Delayed-Release Capsules Usp Plus Amoxicillin And Clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules Usp, In Combination With Amoxicillin And Clarithromycin, Is Indicated For The Treatment Of Patients With Infection And Duodenal Ulcer Disease (active Or History Of Within The Past 5 Years) To Eradicate . Eradication Of Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence H. Pylori H. Pylori H. Pylori [see Dosage And Administration ( ) And Clinical Studies ( )]. 2 14 In Patients Who Fail Therapy, Susceptibility Testing Should Be Done. If Resistance To Clarithromycin Is Demonstrated Or Susceptibility Testing Is Not Possible, Alternative Antimicrobial Therapy Should Be Instituted [ ]. See Clinical Pharmacology ( ) And The Prescribing Information For Clarithromycin 12.4 1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Esomeprazole Magnesium Delayed-Release Capsules Usp Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Shellac SHELLAC Unresolved
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Esomeprazole Magnesium Dihydrate

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