OXFORD PHARMS Application 077209

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69584-148	Cyclobenzaprine HCl	Cyclobenzaprine HCl	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-149	Cyclobenzaprine HCl	Cyclobenzaprine HCl	Oxford Pharmaceuticals, LLC	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
53971	ORIG	2018-05-01