Application 202731

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE 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
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5045	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5046	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5554	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5562	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32294	ORIG	2013-12-06
10099	ORIG	2013-12-06

Application 202731

Related Records#

Application Products#

NDC Listings For This Application#

Documents#