Application 208518

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	TABLET, DELAYED RELEASE;ORAL	10MG;10MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-186	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg	Par Pharmaceutical, Inc.	ANDA	Current
49884-186	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg	Par Pharmaceutical, Inc.	ANDA	Current
49884-186	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg	Par Pharmaceutical, Inc.	ANDA	Current
63629-2184	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg	Bryant Ranch Prepack	ANDA	Current
63629-2184	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg	Bryant Ranch Prepack	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
50987	ORIG	2018-01-08