Application Nr Approved Date Route Status External Links
ANDA202191 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Metoclopramide Orally Disintegrating Tablets Are A Dopamine Receptor Antagonist Indicated For: Relief Of Symptomatic Gastroesophageal Reflux: Short-Term (4 To 12 Weeks) Therapy For Adults With Symptomatic, Documented Gastroesophageal Reflux Who Fail To Respond To Conventional Therapy ( 1.1 ) Diabetic Gastroparesis (Diabetic Gastric Stasis): The Relief Of Symptoms In Adults Associated With Acute And Recurrent Diabetic Gastroparesis (Gastric Stasis) ( 1.2 ) Important Limitations: Therapy Should Not Exceed 12 Weeks In Duration ( 1.3 ) Metoclopramide Hydrochloride Orally Disintegrating Tablets Are Recommended Only For Adults. The Safety And Effectiveness In Pediatric Patients Have Not Been Established ( 1.3 ) 1.1 Symptomatic Gastroesophageal Reflux Disease Metoclopramide Hydrochloride Orally Disintegrating Tablets Are Indicated As Short-Term (4 To 12 Weeks) Therapy For Adults With Symptomatic, Documented Gastroesophageal Reflux Disease (Gerd) Who Fail To Respond To Conventional Therapy. 1.2 Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide Hydrochloride Orally Disintegrating Tablets Are Indicated For The Relief Of Symptoms Associated With Acute And Recurrent Diabetic Gastroparesis (Gastric Stasis) In Adults. 1.3 Important Limitations Metoclopramide Hydrochloride Orally Disintegrating Tablets Are Indicated For Adults Only. Therapy Should Not Exceed 12 Weeks In Duration. The Safety And Effectiveness In Pediatric Patients Have Not Been Established.

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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