Application Nr Approved Date Route Status External Links
ANDA078916 None Oral None 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

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