Application Nr Approved Date Route Status External Links
ANDA077255 2009-11-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lansoprazole Delayed-Release Capsules Are A Proton Pump Inhibitor (ppi) Indicated For The: • Treatment Of Active Duodenal Ulcer In Adults. (1.1) • Eradication Of H. Pylori To Reduce The Risk Of Duodenal Ulcer Recurrence In Adults. (1.2) • Maintenance Of Healed Duodenal Ulcers In Adults. (1.3) • Treatment Of Active Benign Gastric Ulcer In Adults. (1.4) • Healing Of Non-Steroidal Anti-Inflammatory Drugs (nsaid)-Associated Gastric Ulcer In Adults. (1.5) • Risk Reduction Of Nsaid-Associated Gastric Ulcer In Adults. (1.6) • Treatment Of Symptomatic Gastroesophageal Reflux Disease (gerd) In Adults And Pediatric Patients 1 Year Of Age And Older. (1.7) • Treatment Of Erosive Esophagitis (ee) In Adults And Pediatric Patients 1 Year Of Age And Older. (1.8) • Maintenance Of Healing Of Ee In Adults. (1.9) Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (zes) In Adults. (1.10) 1.1 Treatment Of Active Duodenal Ulcer Lansoprazole Delayed-Release Capsules Are Indicated In Adults For Short-Term Treatment (for Four Weeks) For Healing And Symptom Relief Of Active Duodenal Ulcer [see Clinical Studies (14.1)]. 1.2 Eradication Of H. Pylori To Reduce The Risk Of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole Delayed-Release Capsules/amoxicillin/clarithromycin Lansoprazole Delayed-Release Capsules In Combination With Amoxicillin Plus Clarithromycin As Triple Therapy Is Indicated In Adults For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or One Year History Of A Duodenal Ulcer) To Eradicate H. Pylori. Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence [see Clinical Studies (14.2)]. Please Refer To The Full Prescribing Information For Amoxicillin And Clarithromycin. Dual Therapy: Lansoprazole Delayed-Release Capsules/amoxicillin Lansoprazole Delayed-Release Capsules In Combination With Amoxicillin As Dual Therapy Is Indicated In Adults For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or One Year History Of A Duodenal Ulcer) Who Are Either Allergic Or Intolerant To Clarithromycin Or In Whom Resistance To Clarithromycin Is Known Or Suspected (see The Clarithromycin Prescribing Information, Microbiology Section). Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence [see Clinical Studies (14.2)]. Please Refer To The Full Prescribing Information For Amoxicillin. 1.3 Maintenance Of Healed Duodenal Ulcers Lansoprazole Delayed-Release Capsules Are Indicated In Adults To Maintain Healing Of Duodenal Ulcers. Controlled Studies Do Not Extend Beyond 12 Months [see Clinical Studies ( 14.3 )]. 1.4 Treatment Of Active Benign Gastric Ulcer Lansoprazole Delayed-Release Capsules Are Indicated In Adults For Short-Term Treatment (up To Eight Weeks) For Healing And Symptom Relief Of Active Benign Gastric Ulcer [see Clinical Studies ( 14.4 )]. 1.5 Healing Of Nsaid-Associated Gastric Ulcer Lansoprazole Delayed-Release Capsules Are Indicated In Adults For The Treatment Of Nsaid-Associated Gastric Ulcer In Patients Who Continue Nsaid Use. Controlled Studies Did Not Extend Beyond Eight Weeks [see Clinical Studies ( 14.5 )]. 1.6 Risk Reduction Of Nsaid-Associated Gastric Ulcer Lansoprazole Delayed-Release Capsules Are Indicated In Adults For Reducing The Risk Of Nsaid-Associated Gastric Ulcers In Patients With A History Of A Documented Gastric Ulcer Who Require The Use Of An Nsaid. Controlled Studies Did Not Extend Beyond 12 Weeks [see Clinical Studies ( 14.6 )]. 1.7 Treatment Of Symptomatic Gastroesophageal Reflux Disease (gerd) Lansoprazole Delayed-Release Capsules Are Indicated In Adults And Pediatric Patients One Year Of Age And Older For The Treatment Of Heartburn And Other Symptoms Associated With Gerd For Up To Eight Weeks [see Clinical Studies (14.7)]. 1.8 Treatment Of Erosive Esophagitis (ee) Lansoprazole Delayed-Release Capsules Are Indicated For Short-Term Treatment In Adults And Pediatric Patients 12 To 17 Years Of Age (up To Eight Weeks) And Pediatric Patients One To 11 Years Of Age (up To 12 Weeks) For Healing And Symptom Relief Of All Grades Of Ee. For Adults Who Do Not Heal With Lansoprazole Delayed-Release Capsules For Eight Weeks (5 To 10%), It May Be Helpful To Give An Additional Eight Weeks Of Treatment. If There Is A Recurrence Of Erosive Esophagitis An Additional Eight Week Course Of Lansoprazole Delayed-Release Capsules May Be Considered [see Clinical Studies (14.8)]. 1.9 Maintenance Of Healing Of Ee Lansoprazole Delayed-Release Capsules Are Indicated In Adults To Maintain Healing Of Ee. Controlled Studies Did Not Extend Beyond 12 Months [see Clinical Studies (14.9)]. 1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (zes) Lansoprazole Delayed-Release Capsules Are Indicated In Adults For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome [see Clinical Studies ( 14.10 )].

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Shellac SHELLAC Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lansoprazole LANSOPRAZOLE ZINC599734

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