Application Nr Approved Date Route Status External Links
ANDA077824 2006-10-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ranitidine Tablets, Usp Is Indicated In: 1. Short-Term Treatment Of Active Duodenal Ulcer. Most Patients Heal Within 4 Weeks. Studies Available To Date Have Not Assessed The Safety Of Ranitidine In Uncomplicated Duodenal Ulcer For Periods Of More Than 8 Weeks. 2. Maintenance Therapy For Duodenal Ulcer Patients At Reduced Dosage After Healing Of Acute Ulcers. No Placebo-Controlled Comparative Studies Have Been Carried Out For Periods Of Longer Than 1 Year. 3. The Treatment Of Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome And Systemic Mastocytosis). 4. Short-Term Treatment Of Active, Benign Gastric Ulcer. Most Patients Heal Within 6 Weeks And The Usefulness Of Further Treatment Has Not Been Demonstrated. Studies Available To Date Have Not Assessed The Safety Of Ranitidine In Uncomplicated, Benign Gastric Ulcer For Periods Of More Than 6 Weeks. 5. Maintenance Therapy For Gastric Ulcer Patients At Reduced Dosage After Healing Of Acute Ulcers. Placebo-Controlled Studies Have Been Carried Out For 1 Year. 6. Treatment Of Gerd. Symptomatic Relief Commonly Occurs Within 24 Hours After Starting Therapy With Ranitidine Tablets, Usp 150 Mg B.i.d. 7. Treatment Of Endoscopically Diagnosed Erosive Esophagitis. Symptomatic Relief Of Heartburn Commonly Occurs Within 24 Hours Of Therapy Initiation With Ranitidine Tablets, Usp 150 Mg Q.i.d. 8. Maintenance Of Healing Of Erosive Esophagitis. Placebo-Controlled Trials Have Been Carried Out For 48 Weeks. Concomitant Antacids Should Be Given As Needed For Pain Relief To Patients With Active Duodenal Ulcer; Active, Benign Gastric Ulcer; Hypersecretory States; Gerd; And Erosive Esophagitis.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE ZINC1530729

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