Application 078992

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE; ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE; ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE; ORAL	20MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE; ORAL	40MG	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-428	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceuticals, Inc.	ANDA	Current
49884-428	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceuticals, Inc.	ANDA	Current
49884-428	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceuticals, Inc.	ANDA	Current
49884-430	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceuticals, Inc.	ANDA	Current
49884-430	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceuticals, Inc.	ANDA	Current
49884-430	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceuticals, Inc.	ANDA	Current
63629-2172	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2172	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2175	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2175	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Document	Submission type	Date
9211	ORIG	2013-12-05