Application Nr Approved Date Route Status External Links
ANDA078964 2013-11-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Rabeprazole Sodium Delayed-Release Tablet Is A Proton-Pump Inhibitor (ppi) Indicated In Adults For: •healing Of Erosive Or Ulcerative Gastroesophageal Reflux Disease (gerd) (1.1). •maintenance Of Healing Of Erosive Or Ulcerative Gerd (1.2). •treatment Of Symptomatic Gerd (1.3). •healing Of Duodenal Ulcers (1.4). • Helicobacter Pylori Eradication To Reduce Risk Of Duodenal Ulcer Recurrence (1.5). •treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6). In Adolescent Patients 12 Years Of Age And Older For: •short-Term Treatment Of Symptomatic Gerd (1.7). 1.1 Healing Of Erosive Or Ulcerative Gerd In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For Short-Term (4 To 8 Weeks) Treatment In The Healing And Symptomatic Relief Of Erosive Or Ulcerative Gastroesophageal Reflux Disease (gerd). For Those Patients Who Have Not Healed After 8 Weeks Of Treatment, An Additional 8-Week Course Of Rabeprazole Sodium Delayed-Release Tablets May Be Considered. 1.2 Maintenance Of Healing Of Erosive Or Ulcerative Gerd In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For Maintaining Healing And Reduction In Relapse Rates Of Heartburn Symptoms In Patients With Erosive Or Ulcerative Gastroesophageal Reflux Disease (gerd Maintenance). Controlled Studies Do Not Extend Beyond 12 Months. 1.3 Treatment Of Symptomatic Gerd In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For The Treatment Of Daytime And Nighttime Heartburn And Other Symptoms Associated With Gerd In Adults For Up To 4 Weeks. 1.4 Healing Of Duodenal Ulcers In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For Short-Term (up To Four Weeks) Treatment In The Healing And Symptomatic Relief Of Duodenal Ulcers. Most Patients Heal Within Four Weeks. 1.5 Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence In Adults Rabeprazole Sodium Delayed-Release Tablets, In Combination With Amoxicillin And Clarithromycin As A Three Drug Regimen, Are Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or History Within The Past 5 Years) To Eradicate H. Pylori. Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. 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 (12.2) And The Full Prescribing Information For Clarithromycin]. 1.6 Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. 1.7 Treatment Of Symptomatic Gerd In Adolescent Patients 12 Years Of Age And Older Rabeprazole Sodium Delayed-Release Tablets Are Indicated For The Treatment Of Symptomatic Gerd In Adolescents 12 Years Of Age And Above For Up To 8 Weeks.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Diacetylated Monoglycerides DIACETYLATED MONOGLYCERIDES Unresolved
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
5. Lecithin LECITHIN Unresolved
6. 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.
7. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
10. Shellac SHELLAC Unresolved
11. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rabeprazole Sodium RABEPRAZOLE SODIUM ZINC1530935

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