Application Nr Approved Date Route Status External Links
ANDA078279 2015-09-25 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 Capsule Is 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) 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 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 May Be Considered. In Infants 1 Month To Less Than 1 Year, Esomeprazole Magnesium Delayed-Release Capsules Are Indicated For Short-Term Treatment (up To 6 Weeks) Of Erosive Esophagitis Due To Acid-Mediated Gerd. Maintenance Of Healing Of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules 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 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 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. 1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Esomeprazole Magnesium Delayed-Release Capsules Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
5. 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.
6. Simethicone SIMETHICONE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM ZINC4693574

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