Application Nr Approved Date Route Status External Links
ANDA203957 2016-10-14 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: 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 /amoxicillin /clarithromycin Lansoprazole 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 /amoxicillin Lansoprazole 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 Prescribing Information , 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 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)]. 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. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
2. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
6. Hypromelloses HYPROMELLOSES Unresolved
7. Ferric Oxide Red FERRIC OXIDE RED Molecular
8. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
9. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
10. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
11. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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