Details for New Drug Application (NDA): 208518

NDA 208518 describes DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc, 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 208518

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

Pharmacology for NDA: 208518

Ingredient-type	Analogs/Derivatives Vitamin B 6
Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 208518

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518	ANDA	Endo USA, Inc.	49884-186	49884-186-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (49884-186-01)
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518	ANDA	Bryant Ranch Prepack	63629-2184	63629-2184-1	100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2184-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	10MG;10MG
Approval Date:	Dec 6, 2017	TE:	AB	RLD:	No

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