Application Nr Approved Date Route Status External Links
ANDA075805 2001-04-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Famotidine Is Indicated In: 1. Short Term Treatment Of Active Duodenal Ulcer. Most Adult Patients Heal Within 4 Weeks; There Is Rarely Reason To Use Famotidine At Full Dosage For Longer Than 6 To 8 Weeks. Studies Have Not Assessed The Safety Of Famotidine In Uncomplicated Active Duodenal Ulcer For Periods Of More Than Eight Weeks. 2. Maintenance Therapy For Duodenal Ulcer Patients At Reduced Dosage After Healing Of An Active Ulcer. Controlled Studies In Adults Have Not Extended Beyond One Year. 3. Short Term Treatment Of Active Benign Gastric Ulcer. Most Adult Patients Heal Within 6 Weeks. Studies Have Not Assessed The Safety Or Efficacy Of Famotidine In Uncomplicated Active Benign Gastric Ulcer For Periods Of More Than 8 Weeks. 4. Short Term Treatment Of Gastroesophageal Reflux Disease (gerd). Famotidine Is Indicated For Short Term Treatment Of Patients With Symptoms Of Gerd (see Clinical Pharmacology In Adults, Clinical Studies ). Famotidine Is Also Indicated For The Short Term Treatment Of Esophagitis Due To Gerd Including Erosive Or Ulcerative Disease Diagnosed By Endoscopy (see Clinical Pharmacology In Adults, Clinical Studies ). 5.treatment Of Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) (see Clinical Pharmacology In Adults, Clinical Studies ).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. 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.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Famotidine FAMOTIDINE ZINC1530636

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