Application Nr Approved Date Route Status External Links
ANDA091269 2010-10-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lansoprazole Delayed-Release Capsule Is A Proton Pump Inhibitor (ppi) Indicated For: •short-Term Treatment Of Active Duodenal Ulcer (1.1) • H. Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence (1.2) •maintenance Of Healed Duodenal Ulcers (1.3) •short-Term Treatment Of Active Benign Gastric Ulcer (1.4) •healing Of Nonsteroidal Anti-Inflammatory Drugs (nsaid)-Associated Gastric Ulcer (1.5) •risk Reduction Of Nsaid-Associated Gastric Ulcer (1.6) •gastroesophageal Reflux Disease (gerd) (1.7) •maintenance Of Healing Of Erosive Esophagitis (ee) (1.8) •pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (zes) (1.9) 1.1 Short-Term Treatment Of Active Duodenal Ulcer Lansoprazole Delayed-Release Capsules Are Indicated For Short-Term Treatment (for Four Weeks) For Healing And Symptom Relief Of Active Duodenal Ulcer. [see Clinical Studies (14) ] 1.2 H. Pylori Eradication 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 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) ] 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 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 Package Insert, Microbiology Section). Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. [see Clinical Studies (14) ] Please Refer To The Full Prescribing Information For Amoxicillin. 1.3 Maintenance Of Healed Duodenal Ulcers Lansoprazole Delayed-Release Capsules Are Indicated To Maintain Healing Of Duodenal Ulcers. Controlled Studies Do Not Extend Beyond 12 Months. [see Clinical Studies (14 ) ] 1.4 Short-Term Treatment Of Active Benign Gastric Ulcer Lansoprazole Delayed-Release Capsules Are Indicated For Short-Term Treatment (up To Eight Weeks) For Healing And Symptom Relief Of Active Benign Gastric Ulcer. [see Clinical Studies (14) ] 1.5 Healing Of Nsaid-Associated Gastric Ulcer Lansoprazole Delayed-Release Capsules Are Indicated 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) ] 1.6 Risk Reduction Of Nsaid-Associated Gastric Ulcer Lansoprazole Delayed-Release Capsules Are Indicated 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)] 1.7 Gastroesophageal Reflux Disease (gerd) Short-Term Treatment Of Symptomatic Gerd Lansoprazole Delayed-Release Capsules Are Indicated For The Treatment Of Heartburn And Other Symptoms Associated With Gerd For Up To Eight Weeks. [see Clinical Studies (14) ] Short-Term Treatment Of Erosive Esophagitis Lansoprazole Delayed-Release Capsules Are Indicated For Short-Term Treatment (up To Eight Weeks) For Healing And Symptom Relief Of All Grades Of Erosive Esophagitis. For Patients Who Do Not Heal With Lansoprazole Delayed-Release Capsules For Eight Weeks (5 To10%), 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)] 1.8 Maintenance Of Healing Of Erosive Esophagitis (ee) Lansoprazole Delayed-Release Capsules Are Indicated To Maintain Healing Of Erosive Esophagitis. Controlled Studies Did Not Extend Beyond 12 Months. [see Clinical Studies (14) ] 1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (zes) Lansoprazole Delayed-Release Capsules Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. [see Clinical Studies (14) ]

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
3. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS 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. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved
8. Simethicone SIMETHICONE Unresolved
9. Starch STARCH Unresolved SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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