Last Updated: June 17, 2026

Details for New Drug Application (NDA): 207825

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NDA 207825 describes DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Ph Health, and Pharmobedient, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE profile page.

The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

Summary for 207825

Tradename:	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Applicant:	Pharmobedient
Ingredient:	doxylamine succinate; pyridoxine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	10MG;10MG
Approval Date:	Jul 6, 2020	TE:	AB	RLD:	No

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