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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212472

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NDA 212472 describes DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, and Ph Health, and is included in five NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

Summary for 212472

Tradename:	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Applicant:	Actavis Labs Fl Inc
Ingredient:	doxylamine succinate; pyridoxine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG;20MG
Approval Date:	Mar 1, 2022	TE:		RLD:	No

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