Application 202842

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
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	20MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
63629-2171	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2171	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2171	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2173	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2173	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2173	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2174	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2174	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2174	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2176	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2176	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2176	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2177	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2177	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2177	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2178	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2178	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2178	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46034	ORIG	2016-12-06

Application 202842

Related Records#

Application Products#

NDC Listings For This Application#

Documents#