Application Nr Approved Date Route Status External Links
NDA019527 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pepcid 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. Pepcid 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. Pepcid For Oral Suspension Is Indicated In Pediatric Patients From Birth To Less Than 1 Year Of Age For The Treatment Of: • Gerd. Pepcid Is A Histamine-2 (H2) 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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