Application Nr Approved Date Route Status External Links
ANDA070581 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Metoclopramide Tablets Are Indicated For The: Treatment For 4 To 12 Weeks Of Symptomatic, Documented Gastroesophageal Reflux In Adults Who Fail To Respond To Conventional Therapy. Relief Of Symptoms In Adults With Acute And Recurrent Diabetic Gastroparesis. Limitations Of Use: Metoclopramide Tablets Are Not Recommended For Use In Pediatric Patients Due To The Risk Of Developing Tardive Dyskinesia (Td) And Other Extrapyramidal Symptoms As Well As The Risk Of Methemoglobinemia In Neonates [See Use In Specific Populations ( 8.4 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metoclopramide Hydrochloride METOCLOPRAMIDE HYDROCHLORIDE ZINC1530716

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