Application 208861

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
005	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
006	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	No	No
007	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3854	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3854	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3862	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3862	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3869	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3869	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3873	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3873	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3891	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3891	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3895	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3895	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3902	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3902	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
57324	ORIG	2019-01-22