Application 077707

Type: ANDA
Sponsor: TEVA PHARMS

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	20MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5295	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5296	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5297	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22608	ORIG	2012-09-17

Application 077707

Related Records#

Application Products#

NDC Listings For This Application#

Documents#