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Doxylamine succinate

Flagship

Antihistamines

Overview

A first-generation ethanolamine antihistamine used in sleep aids, cold combinations and (with pyridoxine) for nausea in pregnancy. Backed by US-DMF, EDMF and WC-FDA files.

Specifications

CAS562-10-7
StandardUSP
CategoryAPI
Regulatory filesEU WC GD250028 · FDA CPP H9AE-5J4P (Mexico)
Therapeutic areaAntihistamines

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Available under NDA for qualified products.

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Impurity reference standards for this API 10

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GMPUS FDA inspectedUSP