Application Nr Approved Date Route Status External Links
ANDA075511 2001-04-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Famotidine Tablets Are 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 Tablets Are Indicated For Short-Term Treatment Of Patients With Symptoms Of Gerd (see Clinical Pharmacology In Adults, Clinical Studies). Famotidine Tablets Are 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 (8 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. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved

Active Ingredients ( 1 Total)

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

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