Application 211918

Type: ANDA
Sponsor: ANDOR PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	18MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	27MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	36MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	54MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-3310	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3310	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3310	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3310	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3311	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3311	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3311	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3311	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3312	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3312	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3312	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3312	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3313	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3313	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3313	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-3313	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Lannett Company, Inc.	ANDA	Current