Application 078873

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	40MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5292	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5293	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5298	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43149	ORIG	2012-09-26

Application 078873

Related Records#

Application Products#

NDC Listings For This Application#

Documents#