famotidine

FDA Drug Profile — Pepcid, careone acid relief, dg health acid reducer, Famotidine, acid reducer

Drug Details

Generic Name
famotidine
Brand Names
Pepcid, careone acid relief, dg health acid reducer, Famotidine, acid reducer, basic care acid reducer, famotidine, Acid Controller, acid relief, basic care heartburn prevention, equate famotidine, FAMOTIDINE, heartburn relief, acid controller, topcare acid reducer, dg health heartburn prevention
Application Number
ANDA075805
Sponsor
Patheon Inc.
NDC Codes
30
Dosage Forms
TABLET, FILM COATED, INJECTION, SOLUTION, POWDER, FOR SUSPENSION
Routes
ORAL, INTRAVENOUS
Active Ingredients
FAMOTIDINE

Indications and Usage

1 INDICATIONS AND USAGE Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: peptic ulcer disease. GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: GERD. Famotidine for oral suspension is a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence. In pediatric patients 1 year of age and older for the treatment of: peptic ulcer GERD with or without esophagitis and ulcerations In pediatric patients from birth to less than 1 year of age for the treatment of: GERD.