Application 090710

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-228	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-228	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-228	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-229	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-229	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-229	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-230	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-230	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-230	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-1081	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1081	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1082	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1082	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1083	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1083	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1172	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1172	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1172	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current